Recall Z-0533-2025 ยท LRO General Surgery Tray
MEDLINE INDUSTRIES, LP - Northfield
(1) Medline Pacer Implant Pack, REF DYNJ59194A, 4 kits/case, sterile; and (2) Medline Thoracotomy Morristown, REF DYNJ904220F, 1 kit/case, non-sterile.
| Date | Nov 25, 2024 (initiated Oct 15, 2024) |
| Status | Open, Classified |
| Reason | Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length. |
| Root cause | Mixed-up of materials/components |
| Action | The recalling firm issued letters on and dated 10/15/2024 via email and first-class mail explaining the issue, potential risk, and informing the consignee stickers are to be provided upon request to be placed onto the Medline pack instructing that the affected component is to be removed and replaced with an item in inventory. Required actions were included which were to (1) Immediately check your stock for the affected item number and the affected lot numbers which can be located within the recall portal. Quarantine all affected product immediately; (2) Use the link and information in the l |
| Quantity | 360 kits |
| Distribution | US Nationwide distribution in the states of AL, GA, MA, NJ, and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.