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U.S. Department of Health and Human Services

Class 2 Device Recall Composix LP with Echo

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 Class 2 Recall
Composix LP with Echo
see related information
Date Posted June 02, 2014
Recall Status1 Open
Recall Number Z-1693-2014
Recall Event ID 68124
Premarket Notification
510(K) Number
K122436 
Product Classification Laparoscope, General & Plastic Surgery - Product Code GCJ
Product Bard® Ventralight" ST Mesh with Echo PS" 6"x8" Reorder Number: 5955680 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Code Information Lot Number: HUXH0688, HUXK0743, HUXL0803, HUXL0804
Recalling Firm/
Manufacturer
Davol, Inc., Subs. C. R. Bard, Inc.
100 Crossings Blvd
Warwick, Rhode Island 02886-2850
Manufacturer Reason
for Recall
Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging Process Control
Action Davol, Inc., Subs. C. R. Bard, Inc.sent an Urgent Medical Device Recall letter dated April 28, 2014, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to examine their inventory and quarantine product subject to the recall, contact Davol Customer Service at 1-800-556-6275 or C.R. Bard's Medical Services and Support Department at 1-800-562-0027 for instructions on how to return the product to Davol, Consignees were also instructed to complete and return the recall effectiveness check form, and notify their customers if the product was further distributed. For questions regarding this recall call 1-800-556-6275.
Distribution Worldwide Distribution - USA (nationwide) and Internationally to AUSTRIA, BELGIUM, CANADA, CYPRUS, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ITALY, LUXEMBOURG, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GCJ and Original Applicant = C.R. BARD, INC.
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