Recall Z-2095-2023— TELEFLEX LLC

Name: FDA recall Z-2095-2023
Creator: U.S. Food and Drug Administration
Published: 2023-05-25

Class II · Ongoing

Class II FDA medical device recall by TELEFLEX LLC, initiated 2023-05-25. FDA's recall record names no specific 510(k) clearance for this event. Product: Pilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A; ENT retractor. Reason: There are incomplete pre-cleaning instructions within the Instructions for Use (IFU)..

Recalling firm: TELEFLEX LLC
Classification: Class II
Status: Ongoing
Initiated: 2023-05-25
Firm location: Morrisville, NC, United States

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.