(1) Medline Pacer Implant Pack, REF DYNJ59194A, 4 kits/case, sterile; and (2) Medline Thoracotomy Morristown, REF DYNJ904220F, 1 kit/case, non-sterile.
Recall
- Recall Number
- Z-0533-2025
- Event Number
- 95638
- Firm
- MEDLINE INDUSTRIES, LP Northfield
- FEI Number
- 1417592
- Product Code
- LRO
- Status
- Open, Classified
- Root Cause
- Mixed-up of materials/components
- Initiated
- October 15, 2024
- Posted
- November 25, 2024
- Address
- 3 Lakes Dr, Northfield, IL, 60093-2753
Description
(1) Medline Pacer Implant Pack, REF DYNJ59194A, 4 kits/case, sterile; and (2) Medline Thoracotomy Morristown, REF DYNJ904220F, 1 kit/case, non-sterile.
Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
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 letter to complete the response form. List the quantity of affected product in inventory on the form. Upon receipt of the submitted response form, the consignee will receive over-labels to place on affected inventory with instructions for the consignee staff to remove the affected component prior to using the kit. The labels will be provided via FedEx overnight; (4) If the consignee is a distributor or has resold or transferred this product to another company or individual, the consignee is to notify them of the recall communication.
US Nationwide distribution in the states of AL, GA, MA, NJ, and PA.
360 kits