Recalls / —

—#200876

Product

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

FDA product code

KAL — Retractor, Ent

Device class

Class 1

Medical specialty

Ear, Nose, Throat

Affected lot / code info

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

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

Teleflex issued an URGENT MEDICAL DEVICE NOTIFICATION to its consignees on 05/25/2023 by Fed Ex 2nd day delivery. The notice explained the problem, the risk to health, and requested the following actions be taken: Medical facilities are to check the facilities for the product and place a copy of the notice with it. Distributors are directed to check for the product and place a copy of the notice with the product, and notify all customers to whom the product has been distributed.

Recalling firm

Firm

TELEFLEX LLC

Address

3015 Carrington Mill Blvd, Morrisville, North Carolina 27560-5437

Distribution

Distribution pattern

Nationwide and Australia, Canada, S. Korea, Singapore

Timeline

Recall initiated

2023-05-25

Posted by FDA

2023-07-05

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #200876. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.