Sterile packaged wound dressing with white and green inner pouch and outer carton labels, labeled in part:''***V.A.C.*** ABDOMINAL DRESSING WITH NON ADHERENT LAYER***Re-Order No. M6275080/5***Manufactured for Corporate Headquarters: KCI USA, Inc., 8023 Vantage Dr., San Antonio, TX 78230 USA***''.
FDA Recall Z-0873-06 · Posted 2006-05-23
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Recalling FirmKinetic Concepts, Inc
Recall StatusTerminated
Product CodeFTL
Date Initiated2006-03-17
Date Terminated2006-11-22
Product Quantity6453 total units.
Reason for Recall
Complaints received regarding difficulty opening the nonadherent layer of the device prior to application to open abdominal wounds.
Firm Action
Firm sent correction letters on 03/17/06 to all customers who purchased the device since May 2005.
Root Cause
Other
Distribution Pattern
Product distributed nationwide and to the following countries: Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Norway, Spain, Sweden and Switzerland.
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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