Recall Z-1162-2023 ยท LRO General Surgery Tray
MEDLINE INDUSTRIES, LP - Northfield
(1) Medline Sterile Maximum Barrier Pack-LF, Item DYNJ0248546C, 6 kits per case, contains BD Chloraprep Hi-Lite Orange, 10.5 mL Applicator, Vendor PN: 930715NS; (2) Medline Sterile Maximum Barrier Pack-LF, Item DYNJ0248546D, 6 kits per case, contains BD Chloraprep Hi-Lite Orange, 10.5 mL Applicator, Vendor PN: 930715NS.
| 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 | 720 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.