Recall Z-2095-2023 ยท KAL Retractor, Ent
TELEFLEX LLC
Pilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A; ENT retractor
| Date | Jul 5, 2023 (initiated May 25, 2023) |
| Status | Open, Classified |
| Reason | There are incomplete pre-cleaning instructions within the Instructions for Use (IFU). |
| Root cause | Other |
| Action | 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. |
| Quantity | 365 units |
| Distribution | Nationwide and Australia, Canada, S. Korea, Singapore |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.