Device product
Pilling LOWSLEY PROSTATIC TRACTOR CVD, REF 243200; retractor
Z-2096-2023
Product summary
- Firm
- TELEFLEX LLC
- Event
- Event 92416
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 170 units
- Official record key
device-enforcement:Z-2096-2023
Official wording
Reason: There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).
Code information: Lot Numbers: C7, C8, C9, D5, D7, D9, E5, E8, G4, H8, I7, I9, J4, J6, K8, L3, L4, L6, L8, P1, 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).