PlainRecalls
FDA Devices Moderate Class II Ongoing

Pilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A; ENT retractor

Reported: July 12, 2023 Initiated: May 25, 2023 #Z-2095-2023

Product Description

Pilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A; ENT retractor

Reason for Recall

There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).

Details

Recalling Firm
TELEFLEX LLC
Units Affected
365 units
Distribution
Nationwide and Australia, Canada, S. Korea, Singapore
Location
Morrisville, NC

Frequently Asked Questions

What product was recalled?
Pilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A; ENT retractor. Recalled by TELEFLEX LLC. Units affected: 365 units.
Why was this product recalled?
There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).
Which agency issued this recall?
This recall was issued by the FDA Devices on July 12, 2023. Severity: Moderate. Recall number: Z-2095-2023.