FDA Medical devices recall ·
Halyard KIT, SPINE - Medical convenience kits Model Number: EUOR004-03 recall
- Recall number
- Z-0397-2025
- Date
- (initiated September 20, 2024)
- Company / brand
- AVID Medical, Inc.
9000 Westmont Dr, Toano, VA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 174 eaches
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Halyard KIT, SPINE - Medical convenience kits Model Number: EUOR004-03
Why was it recalled?
Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
GTIN: 10809160426463 Lot Number: 1597676
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0397-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.