—#210866

Product

(1) Medline Pacer Implant Pack, REF DYNJ59194A, 4 kits/case, sterile; and (2) Medline Thoracotomy Morristown, REF DYNJ904220F, 1 kit/case, non-sterile.

FDA product code: LRO — General Surgery Tray
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: (1) REF DYNJ59194A - Lot numbers 24DLA916, exp. 12/31/2025; and 24BLA030, exp. 11/30/2025; UDI-DI each 10193489573480, UDI-DI case 40193489573481; and (2) REF DYNJ904220F - Lot number 24DLA070, exp. 11/30/2024, UDI-DI each 10195327362300, UDI-DI case 40195327362301.

Why it was recalled

Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

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.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: US Nationwide distribution in the states of AL, GA, MA, NJ, and PA.

Timeline

Recall initiated: 2024-10-15
Posted by FDA: 2024-11-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #210866. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.