V. Mueller Universal Bandage Scissors Black Plastic Handles Heavy-Duty, Autoclavable, Overall Length 7 (18 cm)- Intended

FDA device recall Z-0737-2024 · posted 2024-01-17 · Open, Classified

Recall details

Recalling firm

Steris Corporation

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.

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

LRW

Quantity affected

4,214 units

Distribution

US Nationwide distribution.

Date initiated

2023-11-16

Date posted

2024-01-17

Location

Mentor, OH