Class 2 Device Recall Teleflex Pilling

• Date Initiated by Firm: May 25, 2023
• Date Posted: July 05, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2095-2023
• Recall Event ID: 92416
• Product Classification: Retractor, ent - Product Code KAL
• Product: Pilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A; ENT retractor
• 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
• FEI Number: 3005747797
• Recalling Firm/ Manufacturer: TELEFLEX LLC; 3015 Carrington Mill Blvd; Morrisville NC 27560-5437
• Manufacturer Reason for Recall: There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).
• FDA Determined Cause: Other
• Action: 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.
• Quantity in Commerce: 365 units
• Distribution: Nationwide and Australia, Canada, S. Korea, Singapore
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.