FDA-Device2023-07-12Class II
Pilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A; ENT retractor
TELEFLEX LLC
Hazard
There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).
Sold states
Nationwide and Australia, Canada, S. Korea, Singapore
Affected count
365 units
Manufactured in
3015 Carrington Mill Blvd, N/A, Morrisville, NC, United States
Products
Pilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A; ENT retractor
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2095-2023Don't want to check this manually?
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