Pilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A; ENT retractor
FDA device recall Z-2095-2023 · posted 2023-07-05 · Open, Classified
Recall details
- Recalling firm
- TELEFLEX LLC
- Reason for recall
- There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).
- 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.
- Root cause
- Other
- Status
- Open, Classified
- Product code
- KAL
- Quantity affected
- 365 units
- Distribution
- Nationwide and Australia, Canada, S. Korea, Singapore
- Date initiated
- 2023-05-25
- Date posted
- 2023-07-05
- Location
- Morrisville, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.