Device product
O.R. SCISSORS, S/B, 5.5 STERILE, Medline Item No. DYND04000
Z-0755-2025
Product summary
- Event
- Event 95843
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 21,440 total
- Official record key
device-enforcement:Z-0755-2025
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: 10193489191349 (ea) 20193489191346 (case); Lot 2023052490
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Sterility assurance
breach of sterility