—#210980

Product

ENDO KIT, Medline Kit SKU DYKE1577A, Component Number 57469, 10 per case; Medline Convenience Kits containing Single Use Biopsy Valve MAJ-1555

FDA product code: FDE — Laparoscopy Kit
Device class: Class 2
Medical specialty: Gastroenterology, Urology
Affected lot / code info: UDI-DI: 10193489844115 (each), 40193489844116 (case); Lot Number 22EBD372

Why it was recalled

Identified lots of Olympus product may be missing sterile and manufacturing lot numbers and expiration dates on the sterile packaging. The information can be found on the outer box or zipper bag label. Medline is recalling its kits which utilize affected product as a component.

Root cause (FDA determination)

Labeling Change Control

Action the firm took

On October 25, 2024, the firm notified customers of the recall via letters titled "Olympus America, Inc. IMMEDIATE ACTION REQUIRED RECALL". Customers were informed that the specified lot of kits may contain the affected lot of Single Use Biopsy Valve MAJ-1555 recalled by Olympus. The missing sterile and manufacturing lot numbers and expiration dates can be found on the outer box or zipper bag label. Affected product should not be used if you are unable to determine the expiration date. Customers should locate and quarantine all product from affected lot. Customers should complete the response form provided by the firm. Upon receipt of the completed form, the firm will provide over-labels to place on affected inventory, with instructions for staff to remove the affected component prior to using the kit. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide distribution in the state of NY.

Timeline

Recall initiated: 2024-10-25
Posted by FDA: 2024-11-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #210980. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.