Device product
ST OR MAYO HEGAR NEEDLEHOLDER 6"(OR2500), Medline Item No. 67870
Z-0756-2025
Product summary
- Event
- Event 95843
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 21,440 total
- Official record key
device-enforcement:Z-0756-2025
Official wording
Reason: Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
Code information: UDI: 00653160196894 (ea) 30653160196895 (case); Lot 2023091290
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Sterility assurance
breach of sterility