Home › Device types › FCH
Tray, Biopsy, Without Biopsy Instruments
FDA product code FCH · Class 1 · Gastroenterology, Urology
229
Registered devices
6
Adverse events
14
Recalls
2
510(k) clearances
Devices with this code
Diversatek Healthcare — DIVERSATEK HEALTHCARE, INC.Diversatek Healthcare — DIVERSATEK HEALTHCARE, INC.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.Diversatek Healthcare — DIVERSATEK HEALTHCARE, INC.ACS — AMERICAN CONTRACT SYSTEMS, INC.ACS — AMERICAN CONTRACT SYSTEMS, INC.Diversatek Healthcare — DIVERSATEK HEALTHCARE, INC.Diversatek Healthcare — DIVERSATEK HEALTHCARE, INC.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.ACS — AMERICAN CONTRACT SYSTEMS, INC.ACS — AMERICAN CONTRACT SYSTEMS, INC.ACS — AMERICAN CONTRACT SYSTEMS, INC.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.ACS — AMERICAN CONTRACT SYSTEMS, INC.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.ACS — AMERICAN CONTRACT SYSTEMS, INC.ACS — AMERICAN CONTRACT SYSTEMS, INC.ACS — AMERICAN CONTRACT SYSTEMS, INC.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.ACS — AMERICAN CONTRACT SYSTEMS, INC.Diversatek Healthcare — DIVERSATEK HEALTHCARE, INC.Busse Hospital Disposables — ROBERT BUSSE & CO., INC.Therapak — Therapak LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-04 | American Contract Systems Inc. | Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. The |
| 2024-05-06 | American Contract Systems, Inc. | Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromise |
| 2024-04-08 | MEDLINE INDUSTRIES, LP - Northfield | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee |
| 2023-11-29 | American Contract Systems, Inc. | During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There i |
| 2023-05-18 | MEDLINE INDUSTRIES, LP - Northfield | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-15 | MEDLINE INDUSTRIES, LP - Northfield | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2022-12-27 | MEDLINE INDUSTRIES, LP - Northfield | The convenience trays had improper placement of some of the components that were in the nonsterile portion of the tray, thus, not receiving sterilization. |
| 2022-11-17 | MEDLINE INDUSTRIES, LP - Northfield | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. |
| 2022-02-22 | Busse Hospital Disposables, Inc. | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a dru |
| 2022-02-22 | Busse Hospital Disposables, Inc. | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a dru |
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