Recall Z-0737-2024
Steris Corporation · initiated November 16, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: UDI-DI: 10885403065866 Lot Numbers: L22XRD, C23XRD, E23XRD, and F23XRD.
Reason for recall
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.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-0737-2024
- Initiated
- November 16, 2023
- Posted by FDA
- January 17, 2024
- Product code
- LRW – Scissors, General, Surgical
- Quantity
- 4,214 units
- Distribution
- US Nationwide distribution.
- Recalling firm
- Steris Corporation, Mentor, OH