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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 Device Recall Composix LP with Echo see related information
Date Initiated by Firm April 24, 2014
Date Posted June 02, 2014
Recall Status1 Terminated 3 on December 23, 2015
Recall Number Z-1684-2014
Recall Event ID 68124
510(K)Number K122436  
Product Classification Laparoscope, general & plastic surgery - Product Code GCJ
Product Composix" LP with Echo PS" 6x8 Reorder Number: 0144680

Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Code Information Lot Number: HUXK0073, HUXK1537
Recalling Firm/
Manufacturer		 Davol, Inc., Subs. C. R. Bard, Inc.
100 Crossings Blvd
Warwick RI 02886-2850
For Additional Information Contact
800-556-6275
Manufacturer Reason
for Recall		 Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.
FDA Determined
Cause 2		 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 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GCJ and Original Applicant = C.R. BARD, INC.
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