Pilling LOWSLEY PROSTATIC TRACTOR STR, REF 243201; retractor
- Company
- Teleflex Llc
- Recall Initiated
- May 25, 2023
- Posted
- July 5, 2023
- Recall Number
- Z-2097-2023
- Quantity
- 32 units
- Firm Location
- Morrisville, NC
Reason for Recall
There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).
Distribution
Nationwide and Australia, Canada, S. Korea, Singapore
Lot / Code Info
Lot Numbers: A6, A7, A8, C3, C8, E6, G9, I8, I9, Q0, S2, W1.
Root Cause
Other
Action Taken
Teleflex issued an URGENT MEDICAL DEVICE NOTIFICATION to its consignees on 05/25/2023 by Fed Ex 2nd day delivery. The notice explained the problem, the risk to health, and requested the following actions be taken: Medical facilities are to check the facilities for the product and place a copy of the notice with it. Distributors are directed to check for the product and place a copy of the notice with the product, and notify all customers to whom the product has been distributed.