Container, Specimen, Sterile
FDA product code FMH · Class I (low risk) · 21 CFR 864.3250 · Pathology
23510(k) clearances
0PMA approvals
21recalls
Manufacturers
- Sage Products, Inc. 4
- C.R. Bard, Inc. 2
- Sherwood Medical Co. 2
- General Clinical Plastics Corp. 1
- Tri-Tech, Inc. 1
- Cordis Corp. 1
- Omnimedical 1
- American Pharmaseal Div. Ahsc 1
- Pollak (Intl.), Ltd. 1
- Abco Dealers, Inc. 1
- Meridian Diagnostics, Inc. 1
- Landmark Plastics 1
- Xomed, Inc. 1
- Urol, Inc. 1
- W.G. Whitney Corp. 1
- Chesire Laboratories 1
- Portex, Inc. 1
- Superior Plastic Products Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K900983 | Tri-Tech Urine Specimen KitFMH · Traditional | Tri-Tech, Inc. | 09/17/1990SE |
| K823763 | Various-Specimen CollectorsFMH · Traditional | Cordis Corp. | 01/19/1983SE |
| K820180 | Calculi Filter CupFMH · Traditional | Omnimedical | 02/05/1982SE |
| K812933 | Lancer Specimen ContainerFMH · Traditional | Sherwood Medical Co. | 11/06/1981SE |
| K802340 | Specimen SetFMH · Traditional | American Pharmaseal Div. Ahsc | 10/10/1980SE |
| K802002 | Urine Specimen Container #'S 1013-1016FMH · Traditional | Pollak (Intl.), Ltd. | 09/09/1980SE |
| K800947 | Midstream Collection KitFMH · Traditional | Sage Products, Inc. | 05/30/1980SE |
| K800309 | Specimen Collection PanFMH · Traditional | Sage Products, Inc. | 02/26/1980SE |
| K800233 | Abco Midstream Urine Collection SetFMH · Traditional | Abco Dealers, Inc. | 02/26/1980SE |
| K792710 | Para-Pak Clean VialFMH · Traditional | Meridian Diagnostics, Inc. | 01/28/1980SE |
| K792156 | Lancer Specimen ContainerFMH · Traditional | Sherwood Medical Co. | 12/10/1979SE |
| K792211 | Speciman Cup & Emesis BasinFMH · Traditional | General Clinical Plastics Corp. | 11/16/1979SE |
| K790915 | Juhn Tym-TapFMH · Traditional | Xomed, Inc. | 06/27/1979SE |
| K790291 | Operating Room Specimen ContainerFMH · Traditional | Sage Products, Inc. | 04/10/1979SE |
| K781557 | 24-HOUR Urine Collection Cooling WrapFMH · Traditional | Sage Products, Inc. | 10/17/1978SE |
| K780167 | Cath Kit, Urine SpecimenFMH · Traditional | C.R. Bard, Inc. | 02/21/1978SE |
| K780057 | Urine Sample Collection KitFMH · Traditional | C.R. Bard, Inc. | 02/21/1978SE |
| K780049 | Specimen Collection DeviceFMH · Traditional | Urol, Inc. | 01/26/1978SE |
| K770387 | UnicatchFMH · Traditional | W.G. Whitney Corp. | 04/05/1977SE |
| K770231 | Mid-Stream Collection SetFMH · Traditional | Chesire Laboratories | 03/30/1977SE |
| K770112 | Specimen CollectorFMH · Traditional | Portex, Inc. | 03/14/1977SE |
| K761191 | 4 1/2 Oz. Graduated Specimen ContainerFMH · Traditional | Superior Plastic Products Corp. | 02/28/1977SE |
| K760496 | Cup, Disposable SpecimenFMH · Traditional | Landmark Plastics | 11/12/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2031-2026 Class II | Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows:…During an internal review, Medline identified higher-than-expected endotoxin levels on a representative… | Medline Industries, LP | 03/19/2026Open, Classified |
| Z-2122-2026 Class II | Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118AMedline has identified issues related to calibration of the equipment used to sterilize and package the… | Medline Industries, LP | 01/07/2026Open, Classified |
| Z-1406-2026 Class II | Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118AMedline has identified issues related to calibration of the equipment used to sterilize and package the… | Medline Industries, LP | 01/07/2026Open, Classified |
| Z-1769-2025 Class II | KliniTray Platte Faxitron ,groB "R" sterile. Tissue resection margin examination…Potential for microbial contamination. | Klinika Mdical Gmb | 04/04/2025Open, Classified |
| Z-1768-2025 Class II | KliniTray. KlinioTray. Tissue resection margin examination board/small. Model Number:…Potential for microbial contamination. | Klinika Mdical Gmb | 04/04/2025Open, Classified |
| Z-3034-2024 Class II | Medline Convenience kits labeled as: 1) KIT, MIDSTREAM, W/BZK/FUNNL,3O, Pack Number…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | MEDLINE INDUSTRIES, LP - Northfield | 04/08/2024Open, Classified |
| Z-1448-2024 Class II | Centurion Manual surgical kits labeled as: a) 15ML SAMPLING TUBE WITH CAP, Product Code…Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails.… | MEDLINE INDUSTRIES, LP - Northfield | 02/23/2024Open, Classified |
| Z-0521-2024 Class II | Cardinal Health Clean Stool Transportation System-For the collection, transportation…Due to a manufacturing defect, certain Para-Pak vials may be at risk for leakage. | Meridian Bioscience Inc | 10/19/2023Open, Classified |
| Z-0519-2024 Class II | Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of…Plastic vials contain a manufacturing defect may cause an increased risk of leakage and presents a risk of… | Meridian Bioscience Inc | 10/19/2023Open, Classified |
| Z-2327-2023 Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.…Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. | MEDLINE INDUSTRIES, LP - Northfield | 05/15/2023Open, Classified |
| Z-1085-2023 Class II | Sterile Procedural Trays, labeled as the following: LS MS PACKSterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | MEDLINE INDUSTRIES, LP - Northfield | 11/17/2022Open, Classified |
| Z-2126-2020 Class II | Samco Bio-Tite Sterile Specimen Container, 120mL/53mm, Bio-Tite Blue Cap Catalog Number:…Product was not irradiated; therefore, they are not sterile and do not meet product specification. | Thermo Fisher Scientific (Monterrey) | 04/29/2020Terminated |
| Z-1067-2020 Class II | Centurion- Pathology Container 1150ST STERILE GRADUATED CONTAINER, 32 OZ. 17070 AI OR…Incomplete seals on the sterile package may compromise the sterility | Centurion Medical Products Corporation | 12/11/2019Terminated |
| Z-0273-2020 Class II | Cardinal Health Brand 120mL/53mm sterile, individual peel pouch specimen container with…Cardinal Health branded specimen containers, may potentially contain plastic shavings on threaded surfaces… | Thermo Fisher Scientific (Monterrey) | 07/18/2019Terminated |
| Z-0272-2020 Class II | Cardinal Health Brand 120mL/53mm sterile specimen container with orange cap, 75…Cardinal Health branded specimen containers, may potentially contain plastic shavings on threaded surfaces… | Thermo Fisher Scientific (Monterrey) | 07/18/2019Terminated |
| Z-2943-2018 Class II | Bard Midstream Urine Collector with Rigid Funnel and Iodophor Prep Pads. Product…Medline notified BMD that the Aplicare Povidone Iodine (PVP-I) Prep Pads were not meeting the iodine assay… | Bard Medical Division | 03/21/2018Terminated |
| Z-0756-2017 Class II | Covidien Precision Specimen Container- 4 oz (118 mL), Plastic Screw Top Cap, OR…Sterility of the outer surface of the container compromised due to packaging defect. | Covidien LLC | 10/14/2016Terminated |
| Z-2710-2015 Class II | CURATION KIT 10/CS Used by medical staff to perform surgical procedures and patient care…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | Customed, Inc | 07/10/2015Terminated |
| Z-0407-2015 Class I | , Catalog # 900-913 Used by medical staff to perform patient care procedures such as…Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the… | Customed, Inc | 10/08/2014Terminated |
| Z-2357-2014 Class I | CURATION KIT - CUSTOMED- (10) GAUZE SPONGE 4" X 4" 16PL Y (4) ABSORBENT TIP APPLICATOR…Customed has determined that there is the possibility that packaging integrity may be compromised on… | Customed, Inc | 05/20/2014Terminated |
| Z-1056-2013 Class III | BD Vacutainer C&S Transfer Straw Kit C&S Preservative Plus Urine Tube. 4.0 ml, 13 X 75…The BD Vacutainer Urinalysis Transfer Straw Kit #364991, Lot 1335484 has preprinted polybags which are… | Becton Dickinson & Company | 02/14/2013Terminated |