Device product
Pilling LOWSLEY PROSTATIC TRACTOR STR, REF 243201; retractor
Z-2097-2023
Product summary
- Firm
- TELEFLEX LLC
- Event
- Event 92416
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 32 units
- Official record key
device-enforcement:Z-2097-2023
Official wording
Reason: There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).
Code information: Lot Numbers: A6, A7, A8, C3, C8, E6, G9, I8, I9, Q0, S2, 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).