Device product
Design Options¿ / Epidural anesthesia kit (10 count carton)
Z-2003-2023
Product summary
- Event
- Event 92523
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3,560 units
- Official record key
device-enforcement:Z-2003-2023
Official wording
Reason: Kits were assembled with the incorrect Filter Straw.
Code information: Model No. 552177, 552155, 552179, 552116; GTIN: 04046955596102, 04046955214440, 04046955596140, 04046964950254; Lot No. 0061853751, 0061854949, 0061855598, 0061855133.
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Kits were assembled with the incorrect Filter Straw.