Apparatus, Suction, Single Patient Use, Portable, Nonpowered
FDA product code GCY · Class I (low risk) · 21 CFR 878.4680 · General, Plastic Surgery
96510(k) clearances
0PMA approvals
99recalls
Manufacturers
- Snyder Laboratories, Inc. 5
- Sherwood Medical Co. 4
- Pudenz-Schulte Medical Research Corp. 4
- Davol, Inc. 4
- Inman Medical Corp. 3
- Inamed Development Co. 3
- Codman & Shurtleff, Inc. 3
- Kendall Healthcare Products Co. Div.Of Tyco Health 2
- Uresil Corp. 2
- O.R. Concepts, Inc. 2
- Mayaguez Medical Center 2
- Sil-Med Corp. 2
- Innovative Surgical Products, Inc. 2
- Dow Corning Corp. Healthcare Industries Materials 2
- American Heyer Schulte 2
- Westmark, Sterile Packing Systems, Inc. (Sps) 2
- Bd Becton Dickinson Vacutainer Systems Preanalytic 2
- Heritage Medical Products 2
- B. Braun Medical, Inc. 1
- Heyer Schulte Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972703 | Redyrob-Closed Wound Drainage SystemGCY · Traditional | B.Braun Medical, Inc. | 10/01/1997SE |
| K971036 | Odontit Autogenous Bone Collection DeviceGCY · Traditional | Interpore Intl. | 06/03/1997SE |
| K963839 | Cordis Suction Reservoir - Model Number: 910-500GCY · Traditional | Cordis Corp. | 12/12/1996SE |
| K960099 | Penrose Drain Models 6001 - 6007GCY · Traditional | Sil-Med Corp. | 03/11/1996SE |
| K950754 | Macro Suction Tube Model No 10061GCY · Traditional | Dlp, Inc. | 04/25/1995SE |
| K936223 | Pressure Irrigating SystemGCY · Traditional | Level 1 Technologies, Inc. | 05/12/1994SE |
| K930615 | Autovac Closed Wound Suction SystemGCY · Traditional | Boehringer Laboratories | 02/22/1994SE |
| K933319 | Birtcher GS-9480 Integrated 3-CHIP Camera/Xenon Light Source Visualization SystemGCY · Traditional | Birtcher Medical Systems, Inc. | 10/27/1993SE |
| K933306 | Imc 5.0MM Irrigation/Aspiration Probe W/HolesGCY · Traditional | Inman Medical Corp. | 10/05/1993SE |
| K933305 | Imc 5.0MM Irrigation/Aspiration ProbeGCY · Traditional | Inman Medical Corp. | 10/05/1993SE |
| K933170 | Inman Poole Tip Suction Probe W/Tubing KitGCY · Traditional | Inman Medical Corp. | 09/16/1993SE |
| K931950 | Poole Tip Suction ProbeGCY · Traditional | Mayaguez Medical Center | 08/11/1993SE |
| K931856 | 5.0 MM Irrigation/Aspiration ProbeGCY · Traditional | Mayaguez Medical Center | 08/10/1993SE |
| K925024 | Orc Tappered Irrigating ProbeGCY · Traditional | O.R. Concepts, Inc. | 05/21/1993SE |
| K923908 | # 9455 and #9457 Poole Tip Suction ProbeGCY · Traditional | O.R. Concepts, Inc. | 05/17/1993SE |
| K920819 | Abdovac (TM), Bellovac (TM) and ExudrainGCY · Traditional | Astra Meditec AB | 03/24/1993SESK |
| K925989 | Kendall Tru-Close Infection Control EvacuatorGCY · Traditional | Kendall Healthcare Products Co. Div.Of Tyco Health | 02/26/1993SE |
| K925749 | Kendall Tru-Close(Tm) Suction Reservoir, 150 MLGCY · Traditional | Kendall Healthcare Products Co. Div.Of Tyco Health | 02/01/1993SE |
| K922895 | J-Vac Bulb Suction ReservoirGCY · Traditional | Johnson & Johnson Medical, Inc. | 09/15/1992SE |
| K915867 | Solcovac Wound Drainage SystemGCY · Traditional | Solco Basle, Inc. | 08/14/1992SESK |
| K915536 | Davol 100CC Silicone Closed Wound Drainage EvacGCY · Traditional | Davol, Inc. | 03/26/1992SE |
| K910167 | Microtek-Heritages Silicone Bulb Evacuation SystemGCY · Traditional | Microbio-Medics, Inc. | 04/15/1991SE |
| K905733 | Seroma-Cath Close Drainage SystemGCY · Traditional | Dawn Medical | 01/28/1991SE |
| K901764 | Inamed Convertible Drain SystemGCY · Traditional | Inamed Development Co. | 05/07/1990SE |
| K901742 | Inamed Small Drain SystemGCY · Traditional | Inamed Development Co. | 05/07/1990SE |
| K896491 | Inamed Closed-Wound Drain SystemGCY · Traditional | Inamed Development Co. | 01/08/1990SE |
| K896803 | Closed Wound ReservoirGCY · Traditional | Westmark, Sterile Packing Systems, Inc. (Sps) | 12/27/1989SE |
| K883982 | DrenovacGCY · Traditional | Iberhospitex, S.A. | 02/23/1989SE |
| K883472 | Closed Wound Suction DeviceGCY · Traditional | Westmark, Sterile Packing Systems, Inc. (Sps) | 10/18/1988SE |
| K883433 | Ambu Twin Pump - (Manual Suction Pump)GCY · Traditional | Ambu, Inc. | 09/02/1988SE |
| K881036 | Hemo Suc Number HS100-HS205GCY · Traditional | Instrumental Medico Croquevielle S.A. | 06/20/1988SE |
| K881012 | Wound-Evac RSGCY · Traditional | Heritage Medical Products | 03/17/1988SE |
| K880650 | Heyer-Schulte(R) 100CC & 400CC Exudate Disp. BagsGCY · Traditional | Baxter Healthcare Corp | 02/24/1988SE |
| K874645 | Closed Wound Drainage SystemsGCY · Traditional | Hall Laboratories, Inc. | 12/02/1987SE |
| K873332 | Maxivac(Tm) Closed Wound Suction Drainage SystemGCY · Traditional | American V. Mueller | 09/08/1987SE |
| K863482 | Drainovac Complete Closed Wound Drainage DeviceGCY · Traditional | Cardio Metrics, Inc. | 10/14/1986SE |
| K863562 | Uresil 150CC Bellows ReservoirGCY · Traditional | Uresil Corp. | 09/29/1986SE |
| K863505 | Uresil Closed Drainage ReservoirGCY · Traditional | Uresil Corp. | 09/18/1986SE |
| K863201 | New Use for Acuvac Suction Reservoir 400CCGCY · Traditional | Allergan, Inc. | 08/29/1986SE |
| K860981 | Aspir-Vac Disposable Surgical Drain SystemGCY · Traditional | Sun Technologies | 05/02/1986SE |
| K854424 | Bard Parker 150CC Bellows ReservoirGCY · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 11/20/1985SE |
| K853295 | Emodren Exchangeable Plastic BellowsGCY · Traditional | Parexel Intl. Corp. | 08/20/1985SE |
| K850634 | Surgidyne Surgiflo C.W.S. Drain ProductsGCY · Traditional | Surgidyne, Inc. | 06/28/1985SE |
| K851084 | Economy 400 CWS with PVC DrainsGCY · Traditional | C.R. Bard, Inc. | 06/04/1985SE |
| K850011 | Provac Wound Healing/Suction SetGCY · Traditional | Medical Matrix, Inc. | 05/21/1985SE |
| K850037 | Closed Wound DrainGCY · Traditional | Consolidated Medical Equipment, Inc. | 03/19/1985SE |
| K844921 | Perimeter Closed Wound ResevoirGCY · Traditional | Perimeter Medical, Inc. | 03/18/1985SE |
| K842710 | Concept C-VacGCY · Traditional | Concept, Inc. | 10/31/1984SE |
| K840913 | Provac Wound Drainage & Healing SysGCY · Traditional | Meyer Medical U.S.A., Inc. | 04/24/1984SE |
| K833586 | TLS Bulb Drainage SystemGCY · Traditional | Porex Medical | 01/30/1984SE |
| K830123 | Disp. Yankaver Surg. Suction InstrumentGCY · Traditional | Narco Scientific | 06/08/1983SE |
| K830607 | Suction ReservoirGCY · Traditional | Sil-Med Corp. | 05/02/1983SE |
| K830510 | BBL Strep Grouping KitGCY · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 05/02/1983SE |
| K823284 | Stryker ConstavacGCY · Traditional | Stryker Corp. | 01/14/1983SE |
| K822902 | Mini-Vac Drain SystemGCY · Traditional | Angus Medical Co. | 12/28/1982SE |
| K822032 | Large Volume Closed Wound Suction DrainGCY · Traditional | American Heyer Schulte | 08/16/1982SE |
| K821563 | Argyle Vac-U-Care 100CC Suction ReservGCY · Traditional | Sherwood Medical Co. | 06/21/1982SE |
| K820474 | P-S Suction ReserviorGCY · Traditional | Pudenz-Schulte Medical Research Corp. | 03/08/1982SE |
| K813377 | Ps-Round Surg. Drain & ConnectorGCY · Traditional | Pudenz-Schulte Medical Research Corp. | 01/05/1982SE |
| K813341 | Wound-EvacGCY · Traditional | Heritage Medical Products | 12/18/1981SE |
| K811557 | Depuy HemodrainGCY · Traditional | Depuy, Inc. | 07/20/1981SE |
| K811203 | Saf Single-Use Aerosol FilterGCY · Traditional | Sorensen Research | 05/21/1981SE |
| K810636 | VariodrainGCY · Traditional | Colmed, Ltd. | 05/01/1981SE |
| K810416 | Sarns Mini-SuckerGCY · Traditional | 3M Health Care, Sarns | 03/05/1981SE |
| K802973 | Ispvac TMGCY · Traditional | Innovative Surgical Products, Inc. | 12/19/1980SE |
| K802214 | Cos-Uphoff Int'L DS-5 Drainage SystemGCY · Traditional | Cox-Uphuff Intl. | 10/23/1980SE |
| K801766 | Jackson-Pratt Large Vol. Closed WoundGCY · Traditional | American Heyer Schulte | 08/20/1980SE |
| K801612 | Frazier-Ferguson Suction Tubes (Disp.)GCY · Traditional | Edward Weck, Inc. | 08/04/1980SE |
| K801443 | P-S Suction ReservoirGCY · Traditional | Pudenz-Schulte Medical Research Corp. | 07/14/1980SE |
| K801442 | P-S Surgical DrainGCY · Traditional | Pudenz-Schulte Medical Research Corp. | 07/14/1980SE |
| K801350 | Acuvac(Tm) Suction Reservoir 400CC andGCY · Traditional | Innovative Surgical Products, Inc. | 07/14/1980SE |
| K801372 | Argyle Vac-U-Care 100CC Suct. ReservoirGCY · Traditional | Sherwood Medical Co. | 06/26/1980SE |
| K801371 | Argyle Vac-U-Care Flat Silicone Wound T.GCY · Traditional | Sherwood Medical Co. | 06/26/1980SE |
| K800578 | Surgivac TMGCY · Traditional | Snyder Laboratories, Inc. | 04/16/1980SE |
| K800577 | Snyder Hemovac TM Vented Wound KitGCY · Traditional | Snyder Laboratories, Inc. | 04/16/1980SE |
| K800543 | Snyder Hysterectomy Y Tube KitGCY · Traditional | Snyder Laboratories, Inc. | 04/16/1980SE |
| K800581 | TLS TM Surgical Drainage SystemGCY · Traditional | Glasrock Products, Inc. | 04/04/1980SE |
| K800542 | 100 ML Snyder HemovacGCY · Traditional | Snyder Laboratories, Inc. | 04/02/1980SE |
| K800331 | Surgitek Foerster Face Lift DrainGCY · Traditional | Medical Engineering Corp. | 03/05/1980SE |
| K800081 | Davol/Abamson Silicone Sump DrainGCY · Traditional | Davol, Inc. | 01/28/1980SE |
| K800014 | Dow Corning/W Right Wound Drainage SysGCY · Traditional | Dow Corning Corp. Healthcare Industries Materials | 01/17/1980SE |
| K790654 | Closed Wound Vacuum Drainage SystemGCY · Traditional | 3M Company | 04/26/1979SE |
| K790763 | Maxi-Vac TMGCY · Traditional | Med General | 04/23/1979SE |
| K782115 | Astra-VacGCY · Traditional | Ab Astra | 02/01/1979SE |
| K782028 | Round Silicone DrainGCY · Traditional | Davol, Inc. | 12/20/1978SE |
| K782026 | Flat Silicone DrainGCY · Traditional | Davol, Inc. | 12/12/1978SE |
| K781400 | Hemovac Tubing Material ChangeGCY · Traditional | Snyder Laboratories, Inc. | 09/20/1978SE |
| K780848 | Portable Closed Wound Suction EvacuatorGCY · Traditional | Biomet, Inc. | 08/23/1978SE |
| K771015 | Vygon Red-O-PackGCY · Traditional | Coastal Bend Medical Products, Inc. | 07/11/1977SE |
| K760778 | T-Tube Drain, RoundGCY · Traditional | Heyer Schulte Corp. | 11/03/1976SE |
| K760700 | Silastic Brand G7-2090AGCY · Traditional | Dow Corning Corp. Healthcare Industries Materials | 11/02/1976SE |
| K760747 | Yasargil Suction Tube - MediumGCY · Traditional | Codman & Shurtleff, Inc. | 11/01/1976SE |
| K760746 | Yasargil Suction Tube - LargeGCY · Traditional | Codman & Shurtleff, Inc. | 11/01/1976SE |
| K760745 | Yasargil Suction Tube - SmallGCY · Traditional | Codman & Shurtleff, Inc. | 11/01/1976SE |
| K760601 | Argyle Suction Control KitGCY · Traditional | Sherwood Medical Co. | 11/01/1976SE |
| K760257 | Sponge, Richards Wound Drainage SystemGCY · Traditional | Richard'S Medical Equip., Inc. | 08/09/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0656-2019 Class II | 8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve), Model…The product was released into commercial distribution while subject to importation refusal. | Covidien LLC | 11/05/2018Terminated |
| Z-2150-2017 Class II | Jackson-Pratt Silicone Flat Drain, 10mm Full W/Trocar. Sterile, Rx Only. For Single Use…Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of… | Cardinal Health 200, LLC | 04/21/2017Terminated |
| Z-2149-2017 Class II | Jackson-Pratt Silicone Flat Drain, 7mm Full W/Trocar. Sterile, Rx Only. For Single Use…Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of… | Cardinal Health 200, LLC | 04/21/2017Terminated |
| Z-2148-2017 Class II | Jackson-Pratt Silicone Round Drain, 19FR. Sterile, Rx Only. For Single Use Only.…Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of… | Cardinal Health 200, LLC | 04/21/2017Terminated |
| Z-2147-2017 Class II | Jackson-Pratt Silicone Round Drain, 15FR. Sterile, Rx Only. For Single Use Only.…Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of… | Cardinal Health 200, LLC | 04/21/2017Terminated |
| Z-2144-2017 Class II | Jackson-Pratt Silicone Flat Drain, 10mm, Full Ducts. Sterile, Rx Only. For Single Use…Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of… | Cardinal Health 200, LLC | 04/21/2017Terminated |
| Z-2143-2017 Class II | Jackson-Pratt Silicone Flat Drain, 7mm, Full Ducts. Sterile, Rx Only. For Single Use…Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of… | Cardinal Health 200, LLC | 04/21/2017Terminated |
| Z-2142-2017 Class II | Jackson-Pratt Silicone Flat Drain, 10mm, 3/4 Ducts. Sterile, Rx Only. For Single Use…Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of… | Cardinal Health 200, LLC | 04/21/2017Terminated |
| Z-2141-2017 Class II | Jackson-Pratt Silicone Flat Drain, 7mm, 3/4 Ducts. Sterile, Rx Only. For Single Use…Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of… | Cardinal Health 200, LLC | 04/21/2017Terminated |
| Z-2140-2017 Class II | Jackson-Pratt PVC Round Drain, 10FR W/Trocar. Sterile, Rx Only. For Single Use Only.…Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of… | Cardinal Health 200, LLC | 04/21/2017Terminated |
| Z-2139-2017 Class II | Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/Trocar. Sterile, Rx Only. For Single…Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of… | Cardinal Health 200, LLC | 04/21/2017Terminated |
| Z-2138-2017 Class II | Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/Trocar. Sterile, Rx Only. For Single…Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of… | Cardinal Health 200, LLC | 04/21/2017Terminated |
| Z-1150-2017 Class II | 9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design M Malar Sizer Set…An incorrect sterility status on the label, non-sterile products labeled as sterile | Stryker Leibinger GmbH & Co. KG | 01/03/2017Terminated |
| Z-1149-2017 Class II | QUINTUBE Monitor Pack (5 tubes/pk, 24 pk/case) (Non-Sterile) SPG Bulb Drain System, 4mm…An incorrect sterility status on the label, non-sterile products labeled as sterile | Stryker Leibinger GmbH & Co. KG | 01/03/2017Terminated |
| Z-1836-2016 Class II | SEAL,IS4000 PORTS,5MM-8MM,BOX of 10; Model numbers: 470361-03, 470361-04, 470361-05…Potential for particulates in insufflation stopcocks on the da Vinci Xi Surgical System cannula seals. The… | Intuitive Surgical, Inc. | 05/09/2016Terminated |
| Z-1610-2015 Class III | Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer Surgical…Devices were placed in a shipper carton without the appropriate number of the Instructions for Use (IFU).… | Zimmer Surgical Inc | 04/21/2015Terminated |
| Z-1569-2015 Class II | 1/4 in. Round Drain with Trocar Curved Trocar with Wound Drain/Double Trocar with Wound…Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential… | Stryker Instruments Div. of Stryker… | 03/26/2015Terminated |
| Z-1568-2015 Class II | 3/16 in. Round Drain with Trocar Curved Trocar with Wound Drain/Double Trocar with Wound…Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential… | Stryker Instruments Div. of Stryker… | 03/26/2015Terminated |
| Z-1567-2015 Class II | 1/4 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with…Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential… | Stryker Instruments Div. of Stryker… | 03/26/2015Terminated |
| Z-1566-2015 Class II | 1/4 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound…Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential… | Stryker Instruments Div. of Stryker… | 03/26/2015Terminated |
| Z-1565-2015 Class II | 1/8 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with…Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential… | Stryker Instruments Div. of Stryker… | 03/26/2015Terminated |
| Z-1564-2015 Class II | 1/8 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound…Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential… | Stryker Instruments Div. of Stryker… | 03/26/2015Terminated |
| Z-1563-2015 Class II | 3/16 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar…Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential… | Stryker Instruments Div. of Stryker… | 03/26/2015Terminated |
| Z-1562-2015 Class II | 3/16 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with…Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential… | Stryker Instruments Div. of Stryker… | 03/26/2015Terminated |
| Z-2224-2015 Class II | Medical Device Exchange - Auto Suture Endo Universal 65 4mm; Pouch, Tyvek/Mylar…EXP did not register as a medical device establishment, list the devices being recalled, or establish its… | EXP Pharmaceutical Services Corp | 02/11/2015Terminated |
| Z-2223-2015 Class II | Medical Device Exchange - Silicone Round Drain; Pouch, Tyvek/Mylar, Sterile, Single Use…EXP did not register as a medical device establishment, list the devices being recalled, or establish its… | EXP Pharmaceutical Services Corp | 02/11/2015Terminated |
| Z-1435-2014 Class II | 7mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) 10…The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound… | Aspen Surgical Products, Inc. | 03/20/2014Terminated |
| Z-1434-2014 Class II | 7mm Drain Kit Flat Full Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile…The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound… | Aspen Surgical Products, Inc. | 03/20/2014Terminated |
| Z-1433-2014 Class II | 19FR Drain Kit Flat Full Perforated with Trocar, Saber 100ml Bulb and 3CSystem, Sterile…The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound… | Aspen Surgical Products, Inc. | 03/20/2014Terminated |
| Z-1432-2014 Class II | 15FR Drain Kit Round End Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile…The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound… | Aspen Surgical Products, Inc. | 03/20/2014Terminated |
| Z-1431-2014 Class II | 10mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case)…The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound… | Aspen Surgical Products, Inc. | 03/20/2014Terminated |
| Z-1430-2014 Class II | 7mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case)…The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound… | Aspen Surgical Products, Inc. | 03/20/2014Terminated |
| Z-1429-2014 Class II | 10mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case)…The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound… | Aspen Surgical Products, Inc. | 03/20/2014Terminated |
| Z-1428-2014 Class II | 10mm Drain Kit Flat Full Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile…The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound… | Aspen Surgical Products, Inc. | 03/20/2014Terminated |
| Z-1427-2014 Class II | 10mm Drain Kit Flat 3/4 Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile…The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound… | Aspen Surgical Products, Inc. | 03/20/2014Terminated |
| Z-1426-2014 Class II | 19FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended…The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound… | Aspen Surgical Products, Inc. | 03/20/2014Terminated |
| Z-1425-2014 Class II | 15FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended…The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound… | Aspen Surgical Products, Inc. | 03/20/2014Terminated |
| Z-1424-2014 Class II | 10FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended…The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound… | Aspen Surgical Products, Inc. | 03/20/2014Terminated |
| Z-1423-2014 Class II | 7mm Drain Kit Fluted 4 Channel with 100ml S-Vac Bulb, Sterile (10/case) Intended for…The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound… | Aspen Surgical Products, Inc. | 03/20/2014Terminated |
| Z-1422-2014 Class II | Saber 100ml Infection Control PVC Bulb Evacuator, Sterile (10/case) Intended to provide…The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound… | Aspen Surgical Products, Inc. | 03/20/2014Terminated |
| Z-1421-2014 Class II | Saber 100ml Infection Control PVC Bulb with 150ml 3C System, Sterile (10/case) Intended…The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound… | Aspen Surgical Products, Inc. | 03/20/2014Terminated |
| Z-1420-2014 Class II | 15FR Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C System…The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound… | Aspen Surgical Products, Inc. | 03/20/2014Terminated |
| Z-1419-2014 Class II | 10FR Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C System…The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound… | Aspen Surgical Products, Inc. | 03/20/2014Terminated |
| Z-1418-2014 Class II | 10mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile (10/case)…The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound… | Aspen Surgical Products, Inc. | 03/20/2014Terminated |
| Z-1417-2014 Class II | 7mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile (10/case)…The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound… | Aspen Surgical Products, Inc. | 03/20/2014Terminated |
| Z-1792-2012 Class II | Lipofilter 3000, model ASP-CAN-2, labeled in part ***MicroAire, 1641 Edlich Drive…Medical device was not manufactured under Good Manufacturing Procedures and a user may be unable to… | MicroAire Surgical Instruments, LLC | 04/26/2012Terminated |
| Z-2012-2011 | Sarns Flexible Weighted Sucker in X-COATED PUMP & TABLE PACK, catalog number 73067-01…The firm has received two reports of the Terumo Weighted Flexible Sucker becoming ensnared in cardiac tissue… | Terumo Cardiovascular Systems Corporation | 02/25/2011Terminated |
| Z-2011-2011 | Sarns Flexible Weighted Sucker in CUSTOM X-COATED PERFUSION PACK, catalog number…The firm has received two reports of the Terumo Weighted Flexible Sucker becoming ensnared in cardiac tissue… | Terumo Cardiovascular Systems Corporation | 02/25/2011Terminated |
| Z-2010-2011 | Sarns Flexible Weighted Sucker in CUSTOM X-COATED PERFUSION PACK, catalog number…The firm has received two reports of the Terumo Weighted Flexible Sucker becoming ensnared in cardiac tissue… | Terumo Cardiovascular Systems Corporation | 02/25/2011Terminated |
| Z-2009-2011 | Sarns Flexible Weighted Sucker in X-COATED CUSTOM TUBING PACK, catalog number 70932-01…The firm has received two reports of the Terumo Weighted Flexible Sucker becoming ensnared in cardiac tissue… | Terumo Cardiovascular Systems Corporation | 02/25/2011Terminated |