Device product
Pilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A; ENT retractor
Z-2095-2023
Product summary
- Firm
- TELEFLEX LLC
- Event
- Event 92416
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 365 units
- Official record key
device-enforcement:Z-2095-2023
Official wording
Reason: There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).
Code information: Lot Numbers: B5, B6, B9, C6, C7, D2, D6, E5, E9, F2, F3, F5, F8, G4, G5, G9, I3, I4, I7, I8, J2, J3, K4, K5, K7, K8, L2, L9, O2, Q0, R2, S2, U0, V2, W1
Distribution pattern: Nationwide and Australia, Canada, S. Korea, Singapore
Derived failure modes
-
Unknown
There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).