Z-2095-2023 Class II Ongoing

Recalled by TELEFLEX LLC — Morrisville, NC

Recall Details

Product Type
Devices
Report Date
July 12, 2023
Initiation Date
May 25, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
365 units

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).

Distribution Pattern

Nationwide and Australia, Canada, S. Korea, Singapore

Code Information

Lot Numbers: B5, B6, B9, C6, C7, D2, D6, E5, E9, F2, F3, F5, F8, G4, G5, G9, I3, I4, I7, I8, J2, J3, K4, K5, K7, K8, L2, L9, O2, Q0, R2, S2, U0, V2, W1