Recall Z-1161-2023 ยท FCH Tray, Biopsy, Without Biopsy Instruments
MEDLINE INDUSTRIES, LP - Northfield
Medline Sterile Oncology Port Access Tray, Item #DYNDC2239, 20 sterile kits per case, containing Ethicon Biopatch Protective Disk with CHG, Disk with Chlorhexidine Gluconate (CHG), DRSG Biopatch 1IN NS, VPN: 10150;
| Date | Feb 23, 2023 (initiated Dec 27, 2022) |
| Status | Open, Classified |
| Reason | The convenience trays had improper placement of some of the components that were in the nonsterile portion of the tray, thus, not receiving sterilization. |
| Root cause | Nonconforming Material/Component |
| Action | Recall letters dated 12/27/2022 were issued via email on 12/27/2022 or via U.S. mail for customers who haver not previously used the Medline Recall Portal. The customer was informed of the issue and told that any affected kits found are to be stickered with labels indicating to remove and replace the affected component from a different sterile supply and return the kit to the customer inventory. The remaining components are acceptable for use. If the customer has the affected kits, they are to indicate the quantity on the response and stickers will be sent to them for placement on the kits |
| Quantity | 4,360 trays |
| Distribution | US Nationwide distribution in the states of AR, CO, and GA. There was no foreign/military/government distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.