—#197709

Product

Non-sterile procedural trays labeled as LAPAROTOMY CDS, 2 per case

FDA product code: FDE — Laparoscopy Kit
Device class: Class 2
Medical specialty: Gastroenterology, Urology
Affected lot / code info: Item Number: CDS980894A, UDI/GTIN Case: 40889942401292, UDI/GTIN Each: 10889942401291, Lot Numbers: 22HMD613, 22JMB665

Why it was recalled

Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging.

Root cause (FDA determination)

Device Design

Action the firm took

Medline Industries, LP notified consignees via email and first-class mail on 11/21/2022. Consignees were instructed to over-label the sterile kits with a warning label indicating Warning To Avoid Injury, Please Handle Blades with Care . For the Non-Sterile kits, they are to over label the affected kits indicating to remove the blades and replace from a different sterile supply. No product is to be returned. Customers were also instructed to complete and return the response form.

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 AR, MD, WA, WI.

Timeline

Recall initiated: 2022-11-17
Posted by FDA: 2023-01-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #197709. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.