• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Pilling Wecksorb

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  Class 2 Device Recall Pilling Wecksorb see related information
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/
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.