V. Mueller Universal Bandage Scissors Black Plastic Handles Heavy-Duty, Autoclavable, Overall Length 7 (18...
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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0737-2024 | Class II | Ongoing | Voluntary: Firm initiated |
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