BardVentralight" ST Mesh with Echo PS" 10"x13" Reorder Number: 5955113 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
FDA Recall Z-1687-2014 · Posted 2014-06-02
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Recalling FirmDavol, Inc., Subs. C. R. Bard, Inc.
Recall StatusTerminated
Product CodeGCJ
Date Initiated2014-04-24
Date Terminated2015-12-23
Reason for Recall
Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.
Firm 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.
Root Cause
Packaging process control
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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