Z-2097-2023 Class II Ongoing
FDA device recall Z-2097-2023 was initiated by TELEFLEX LLC on May 25, 2023 and is designated Class II. Reason for recall: There are incomplete pre-cleaning instructions within the Instructions for Use (IFU). The recall status is ongoing. Affected quantity: 32 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 12, 2023
- Initiation Date
- May 25, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32 units
Product Description
Pilling LOWSLEY PROSTATIC TRACTOR STR, REF 243201; retractor
Reason for Recall
There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).
Distribution Pattern
Nationwide and Australia, Canada, S. Korea, Singapore
Code Information
Lot Numbers: A6, A7, A8, C3, C8, E6, G9, I8, I9, Q0, S2, W1,