—#204962

Product

V. Mueller Universal Bandage Scissors Black Plastic Handles Heavy-Duty, Autoclavable, Overall Length 7 (18 cm)- Intended to cut through tape and bandages Model: SU2014-001

FDA product code: LRW — Scissors, General, Surgical
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: UDI-DI: 10885403065866 Lot Numbers: L22XRD, C23XRD, E23XRD, and F23XRD.

Why it was recalled

Bandage Scissors handle cover component contains an incorrect color masterbatch resin carrier. This may allow a pink dye/residue to appear on the Bandage Scissors and/or sterilization pouches after processing.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Steris issued Urgent Medical Device Recall Letter to Distributors and Customers on November 16, 2023. Letter states reason for recall, health risk and action to take: Please ensure the following steps are completed: 1. Please immediately inspect your on-hand inventory for product affected by this recall. 2. Please complete the Medical Device Recall Response Form included with this letter and destroy any remaining product in your inventory. STERIS will coordinate credit issuance upon receipt of the completed Recall Response Form. 3. Return the completed Recall Response Form via email to: Regulatory_Compliance@STERIS.com or via fax to (440) 392-8963. If you have any questions regarding this recall, please contact regulatory_Compliance@STERIS.com.

Recalling firm

Firm: Steris Corporation
Address: 5960 Heisley Rd, Mentor, Ohio 44060-1834

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2023-11-16
Posted by FDA: 2024-01-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #204962. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.