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

FDA Recall #Z-2095-2023 — Class II — May 25, 2023

Recall #Z-2095-2023 Date: May 25, 2023 Classification: Class II Status: Ongoing

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).

Recalling Firm

TELEFLEX LLC — Morrisville, NC

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

365 units

Distribution

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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