V. Mueller Universal Bandage Scissors Black Plastic Handles Heavy-Duty, Autoclavable, Overall Length 7 (18 cm)- Intende
Summary
The FDA issued a Class II for V. Mueller Universal Bandage Scissors Black Plastic Handles Heavy-Duty, Autoclav by Steris Corporation. Reason: Bandage Scissors handle cover component contains an incorrect color masterbatch resin carrier. This may allow a pink dye/residue to appear on the Band.
Details
Source
Device Recall
External ID
Z-0737-2024
Action Date
2024-01-24
Status
Ongoing
Category
device
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
Lot/Code Info: UDI-DI: 10885403065866 Lot Numbers: L22XRD, C23XRD, E23XRD, and F23XRD.
Quantity Affected: 4,214 units
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.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-16
Company
Mentor, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 203 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Steris Corporation has 71 FDA actions in our database, including 28 recalls and 43 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Steris Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Steris Corporation have FDA actions?
Steris Corporation has 71 FDA actions in our database, including 28 recalls and 43 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0737-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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