FDA Recall Open, Classified

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

Recall: Z-0737-2024 · Initiated November 16, 2023

Recall

Recall Number
Z-0737-2024
Event Number
93610
Firm
Steris Corporation
FEI Number
1527821
Product Code
LRW
Status
Open, Classified
Root Cause
Under Investigation by firm
Initiated
November 16, 2023
Posted
January 17, 2024
Address
5960 Heisley Rd, Mentor, OH, 44060-1834

Description

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

Reason

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.

Action

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: [email protected] or via fax to (440) 392-8963. If you have any questions regarding this recall, please contact [email protected].

Distribution

US Nationwide distribution.

Quantity

4,214 units