Device product
ST IUD REMOVAL HOOK 10" (504090), Medline Item No. I68785
Z-0759-2025
Product summary
- Event
- Event 95843
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 21,440 total
- Official record key
device-enforcement:Z-0759-2025
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: 10653160327141 (ea) 00653160327144 (case); Lot 2023021390
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Sterility assurance
breach of sterility