Date Initiated by Firm |
September 28, 2022 |
Date Posted |
December 28, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0772-2023 |
Recall Event ID |
91312 |
510(K)Number |
K791871
|
Product Classification |
Gauze/sponge, internal - Product Code EFQ
|
Product |
Pilling Wecksorb Cylindrical Sponges |
Code Information |
Catalog Number: 200400, Lot Number: 22B0395 |
Recalling Firm/ Manufacturer |
TELEFLEX LLC 3015 Carrington Mill Blvd Morrisville NC 27560-5437
|
Manufacturer Reason for Recall |
Specific lost have not been irradiated to eliminate pyronema and, therefore, the sterility of the affected products may be compromised.
|
FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
Consignees were notified on about 09/28/2022, via letter. Consignees were instructed to immediately discontinue use and quarantine the products on hand, complete and return the enclosed Acknowledgement Form via fax to 1-855-419-8507 or email to recalls@teleflex.com. A customer service representative will contact you with a Return Goods Authorization (RGA) number and provide instructions for the return of
products. |
Quantity in Commerce |
1,000 units |
Distribution |
Domestic distribution to IL, MS, PA, TN. |
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.
|
510(K) Database |
510(K)s with Product Code = EFQ and Original Applicant = CARWILD CORP.
|