Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0737-2024Class II

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

STERIS Corporation / initiated 2023-11-16 / Open, Classified / root cause: packaging

Steris Corporation began a recall of V. Mueller Universal Bandage Scissors Black Plastic Handles Heavy-Duty, Autoclavable, Overall Length 7 (18 cm)- Intended to cut through tape and bandages... on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number
Z-0737-2024
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
STERIS Corporation
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
Product code
LRW Scissors, General, Surgical
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.
Root cause tag
packaging
FDA root cause
Under Investigation by firm
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].
Quantity in commerce
4,214 units
Distribution
US Nationwide distribution.
Product codes and lots
UDI-DI: 10885403065866 Lot Numbers: L22XRD, C23XRD, E23XRD, and F23XRD.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0737-2024
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0737-2024Class IIOngoingVoluntary: Firm initiated