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U.S. Department of Health and Human Services

Class 2 Device Recall Teleflex Pilling

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  Class 2 Device Recall Teleflex Pilling see related information
Date Initiated by Firm May 25, 2023
Date Posted July 05, 2023
Recall Status1 Open3, Classified
Recall Number Z-2096-2023
Recall Event ID 92416
Product Classification Retractor - Product Code GAD
Product Pilling LOWSLEY PROSTATIC TRACTOR CVD, REF 243200; retractor
Code Information Lot Numbers: C7, C8, C9, D5, D7, D9, E5, E8, G4, H8, I7, I9, J4, J6, K8, L3, L4, L6, L8, P1, S2, U0, V2, W1
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 2		 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 170 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.
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