Device product
Bilateral Tubal Ligation Pack, FHBT3T; Medical convenience kit
Z-3233-2024
Product summary
- Event
- Event 95261
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 18 units
- Official record key
device-enforcement:Z-3233-2024
Official wording
Reason: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Code information: UDI-DI: 00191072178107; Lot: 2405102; Exp: 05/10/2025
Distribution pattern: US Nationwide distribution in the states of MO, MN, MA, OH, NE.
Derived failure modes
-
Potency or specification failure
out-of-specification