Tray, Biopsy, Without Biopsy Instruments
FDA product code FCH · Class I (low risk) · 21 CFR 876.4730 · Gastroenterology, Urology
2510(k) clearances
0PMA approvals
14recalls
Manufacturers
510(k) clearances
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0170-2026 Class II | Basic Biopsy Tray, Item Number NMBP44LIdentified products were re-gassed (sterilized more than once) after a nonconformance occurred during the… | American Contract Systems Inc. | 09/04/2025Open, Classified |
| Z-2523-2024 Class II | American Contract Systems Biopsy Drape Pack convenience kitProduct released with insufficient aeration time impacting the kits sterilized on the same cycle or in the… | American Contract Systems, Inc. | 05/06/2024Open, Classified |
| Z-3004-2024 Class II | Medline Convenience kits labeled as: 1) FETOSCOPY CDS-LF, Pack Number CDS840215O ; 2)…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-0821-2024 Class II | Custom procedural convenience kits and trays, gastroenterological & urological, labeled…During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and… | American Contract Systems, Inc. | 11/29/2023Open, Classified |
| Z-2173-2023 Class II | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a)…Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | MEDLINE INDUSTRIES, LP - Northfield | 05/18/2023Open, Classified |
| Z-2310-2023 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-1161-2023 Class II | Medline Sterile Oncology Port Access Tray, Item #DYNDC2239, 20 sterile kits per case…The convenience trays had improper placement of some of the components that were in the nonsterile portion… | MEDLINE INDUSTRIES, LP - Northfield | 12/27/2022Open, Classified |
| Z-1073-2023 Class II | Sterile Procedural Trays, labeled as the following: a. MINOR/BREAST BIOPSY-LF b. BREAST…Sterile 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-1176-2022 Class II | Core Biopsy Tray Catalog Number: 8673R4Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional… | Busse Hospital Disposables, Inc. | 02/22/2022Terminated |
| Z-1165-2022 Class II | Stereo Breast Biopsy Tray Catalog Number: 2383R1Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional… | Busse Hospital Disposables, Inc. | 02/22/2022Terminated |
| Z-0895-2017 Class II | BREAST PACK, Surgical Instrument Tray, REF/Catalog No. 5406, STERILE, Rx Only -- busse…Covidien issued a labeling update for the Covidien Devon Light Gloves. Busse had incorporated the affected… | Robert Busse & Co. Inc. d.b.a. Busse… | 11/15/2016Terminated |
| Z-1234-2017 Class II | CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile…Sterility of syringe product could not be assured. | Custom Medical Specialties, Inc. | 09/20/2016Open, Classified |
| Z-0797-2013 Class II | Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in bags, 1…Surgical procedure trays are packed with pharmaceuticals for injection that may contain particulate matter. | Custom Healthcare Systems, Inc. | 11/26/2012Terminated |
| Z-0796-2013 Class II | Custom Breast Biopsy Tray, Catalog # B 9-16261, packaged in bags, 1 tray/bag, 20…Surgical procedure trays are packed with pharmaceuticals for injection that may contain particulate matter. | Custom Healthcare Systems, Inc. | 11/26/2012Terminated |