Recalls / —

—#207015

Product

Medline medical procedure kits labeled as follows: a) ENDO KIT, REF DYK1012268E1

FDA product code

NWU — Endoscope Introducer Kit

Device class

Class 2

Medical specialty

Gastroenterology, Urology

Affected lot / code info

a) REF DYK1012268E1, UDI/DI 40884389919089 (case), 10884389919088 (unit), Lot Numbers: 22FBU931, 22HBL619, 22JBG192, 22LBH957, 23CBU467, 23FBS319, 23IBT789, 23KMH977

Why it was recalled

A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Medline Industries issued a Safety Alert to its consignees on 03/22/2024 via email and certified mail. The notice explained the problem with the device and requested that consignees follow the instructions for use. Distributors or those who further transferred the affected product were directed to notify their consignees.

Recalling firm

Firm

MEDLINE INDUSTRIES, LP Northfield

Address

3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern

Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.

Timeline

Recall initiated

2024-03-22

Posted by FDA

2024-08-22

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #207015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.