Pilling LOWSLEY PROSTATIC TRACTOR CVD, REF 243200; retractor
- Company
- Teleflex Llc
- Recall Initiated
- May 25, 2023
- Posted
- July 5, 2023
- Recall Number
- Z-2096-2023
- Quantity
- 170 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: C7, C8, C9, D5, D7, D9, E5, E8, G4, H8, I7, I9, J4, J6, K8, L3, L4, L6, L8, P1, S2, U0, V2, 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.