—#211352

Product

RUMMELL, Medline Item No. ST006ST

FDA product code: LRP — Tray, Surgical
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: UDI: 10653160251224 (ea) 00653160251227 (case); Lot 2023111490

Why it was recalled

Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.

Root cause (FDA determination)

Process control

Action the firm took

On November 25, 2024, the firm notified customers via letters titled IMMEDIATE ACTION REQUIRED. Customers were informed that specific items and lots of Pure Pouch Single-Sterile and Sterile Kits are being recalled due to weak seals. Affected product must be destroyed. The letter included instructions on actions to take to be issued a credit. Customers should immediately check their stock for affected product and quarantine all units. Affected lots should be destroyed. When the recalling firm has received your completed destruction form, your account will be issued a credit, if applicable. If you have any questions, please contact 866-359-1704.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2024-11-12
Posted by FDA: 2024-12-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #211352. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.