—#201123

Product

MEDLINE NON-STERILE PVP SOLUTION, STERILE PACKAGING REF DYNDA2232A

FDA product code: LRO — General Surgery Tray
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: GTIN 10889942851850, Batch Numbers: 2023011090, 2023011190, 2023011790, 2023012090, 2023012590, 2023020790, 2023022390, 2023022490

Why it was recalled

Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".

Root cause (FDA determination)

Process control

Action the firm took

Medline issued a recall notice on 06/02/2023 to its consignees via USPS first class mail. The notice explained the problem with the product and requested the destruction of the product. Medline identified additional products, lots, and consignees and notified their consignees by email on 06/09/2023. Upon receipt of the submitted response form each account will receive over-labels to affix to the affected kits via FedEx overnight, if applicable. distributors were directed to notify their customers and collect the returned product and return it to Medline.

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the country of Panama.

Timeline

Recall initiated: 2023-05-18
Posted by FDA: 2023-07-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #201123. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.