Pilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A; ENT retractor
This recall is currently active, issued July 5, 2023. It was issued by Teleflex Llc.
- Company
- Teleflex Llc
- Recall Initiated
- May 25, 2023
- Posted
- July 5, 2023
- Recall Number
- Z-2095-2023
- Quantity
- 365 units
- Firm Location
- Morrisville, NC
- Official Source
- View on FDA website ↗
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: B5, B6, B9, C6, C7, D2, D6, E5, E9, F2, F3, F5, F8, G4, G5, G9, I3, I4, I7, I8, J2, J3, K4, K5, K7, K8, L2, L9, O2, Q0, R2, 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.