Recall Z-0568-2009
Sterilmed Inc · initiated August 8, 2008
Product
RF Arthroscopy Probe Model #'s: ARTA1325-01 ARTA1335-01 ARTA1345-01 ARTA1730-01 ARTA2630-01 ARTA3625-01 ARTA4330-01 ARTAS1335-01 ARTAS4630-01 ARTASC1335-01 ARTASC2530-01 ARTASC4250-01 ARTASC4830-01 ARTASC5000-01 ARTASC5500-01 ARTEIC4845-01 MIT225203 MIT225301 MIT225302 MIT225305 MIT225350 MIT225360 SMI7209681 SMI7209682 SMI7209683 and STR278-510-500 These devices are designed for general surgical use, including orthopedic and arthroscopic applications or resection, ablation, excision of soft tissue, hemostatis of blood vessels, and coagulation of soft tissue.
Codes / lots: n/a
Reason for recall
SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on one end. A breach in packaging seal or a failure in packaging integrity has the possibility of risk to the patient in terms of transmitting organisms capable
FDA-determined cause: Packaging process control
Action taken
Consignees were notified of the recall via verbal communication in person by on-site technician and or their local sales representative on 8/8/08. Others were contacted via fax or e-mail followed by on-site visits 8/11/08. SteriMed also provided consignees (Materials Manager/Risk Manager) with a "Urgent Product Removal" recall letter (August 14, 2008) in person informing them of the potential of receiving affected product. Included in the Product Removal Notification was a Customer Reply Form to inventory quantity of product received and quantity returned. Contact SterilMed, Inc. at 1-888-541-0078 for assistance.
Details
- Recall number
- Z-0568-2009
- Initiated
- August 8, 2008
- Posted by FDA
- January 13, 2009
- Terminated
- April 26, 2011
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Quantity
- 163
- Distribution
- AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, MA, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, WI, and WV OUS: CANADA
- Recalling firm
- Sterilmed Inc, Osseo, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0546-2009 | Balloon Inflation Device Model #'s: MED15-105 MED15-106 and SCI04527-01 The reprocessed…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0547-2009 | Bed Check Model #'s: BED65815-021 BED65815-025 BED65815-025IT BED65815-030 BED65815-031…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0548-2009 | Drill Bits Model #'s: DEP14043 MIC8053-019 RIC21-0438 RIC21-0439 RIC21-0441 RIC21-0442…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0549-2009 | Biopsy Forceps, Hot Model #'s: BAL60110 BAR000852 BAR000854 and MIC1550 Laparoscopic…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0550-2009 | Burrs Model #'s: ANSL-3SB ANSL-5D ANSQD11-4OVDC HAL5056-118 HAL5056-166 HAL5091-106…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0551-2009 | Cardiac Imaging Catheter Model #'s: ACU08267996 and ACU55790 Intended for intravascular…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0552-2009 | Colorado Electrodes Model #'s: COLN104A COLN112A and STRN103A Intended for precision…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0553-2009 | Compression Sleeves Model #'s: HUNDVT10-1 and KEN5329 The SterilMed Intermittent…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0554-2009 | EP Cables Model #'s: BAR560004P BIOC10MR10MSTKS BIOC5-MH/NAVMH-S CORC6-MR10/EPTR-S…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0555-2009 | EP Catheter Model #'s: BIOD6-DR-005-RT BIOD6-DR-010-RT DAI401381 DAI401449 DAI401904…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0556-2009 | External Fixation Device Model #'s: ORT99-36501 SYN390.005 SYN390.008 SYN394.84…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0557-2009 | Femoral Compression Device Model #'s: RAD11163 Intended for use in the compression of…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0558-2009 | Guidewires - Endoscopic (Jag Wires) Model #'s: MIC5658 and MIC630-100 Intended to be…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0559-2009 | Harmonic Scalpel Model #'s: ETHACE14S ETHACE23P ETHACE36P ETHCS14C ETHFCS9 ETHHDH05…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0560-2009 | Lap Instruments/Graspers/Forceps - HOT Model #'s: AUT173016 AUT174301 AUT176643…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0561-2009 | Lap Instruments/Graspers/Forceps - COLD Model #'s: AUT173030 AUT174233 AUT174317…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0562-2009 | Laser Probe Model #': SYN55.26.25 Reprocessed laser probes are part of a laser delivery…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0563-2009 | Masks - Laryngeal Model #'s: AMB321-300-000 AMB321-400-000 AMB321-500-000 LMA12015…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0564-2009 | Multi-Clip Applier Model #'s: APPCA080 AUT134031 AUT134046 AUT134051 AUT134053 AUT176625…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0565-2009 | Phaco Tips Model #'s: ALC30RTS ALC8065740806 ALC8065740809 ALC8065740837 ALC8065740839…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0566-2009 | Rasps Model #'s: KOMKM5100-37-113 KOMKM-82 STR1675-115 STR5100-37-113 and STR5100-37-115…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0567-2009 | Retractors Model #'s: ADE3204 BOS820-175 LON3304 and LON3334-4G A manual surgical…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0569-2009 | Saw Blade Model #'s: BIO506112 BIO506113 DEP2555-91-000 DEP5627-11-500 HAL5023-118…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0570-2009 | Scissor Tips Model #'s: AESPO888 AESPO889 ENCES0102 MIC3112 MIC3122 MIC3142 MIC3152…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0571-2009 | Stone Retrieval Basket Model #': BOS390-105 Used to entrap and remove renal stones and…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0572-2009 | Tourniquet Cuffs Model #'s: INSDT-7024-02 INSDT-7218-01 SMI553322 SMI7010-7002…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0573-2009 | TURP Electrodes Model #'s: CIRMLE-24-012 CIRMLE-24-015 OLYA22205C STO27050F STO27050G…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0574-2009 | Open & Unused Items - This refers to a sterilization service provided by by SterilMed…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0575-2009 | Biopsy Forceps, Cold Model #'s: BAR000386 BAR000388 MIC1012 MIC1331 MIC1333 MIC1337…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0576-2009 | Taps Model #'s: SYN311.15 SYN311.190 SYN311.39 and SYN311.32 An orthopedic manual…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |