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V. Mueller recallZ-0737-2024 · Steris Corporation · initiated Nov 16, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Steris Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Under Investigation by firm

What the company is doing

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].

Recall details

Recall number
Z-0737-2024
Status
Open, Classified
Initiated by the company
Nov 16, 2023
Posted by the FDA
Jan 17, 2024
Recalling firm
Steris Corporation
Quantity
4,214 units
Product code
LRW
Distribution
US Nationwide distribution.

Product 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

Code information (models, lots, serial numbers)

UDI-DI: 10885403065866 Lot Numbers: L22XRD, C23XRD, E23XRD, and F23XRD.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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