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Terminated

V.A.C. X-Large Granufoam Dressing Part Numbers M6275065/5, V.A.C. ATS and V.A.C. Freedom and M6275043/5 V.A.C. Classic. Manufactured by Kinetic Concepts, Inc., San Antonio, Texas 78230

FDA Recall Z-0038-05 · Posted 2004-10-22

Recalling FirmKinetic Concepts, Inc
Recall StatusTerminated
Product CodeJCX
Date Initiated2004-09-21
Date Terminated2005-06-07
Product Quantity29610 units

Reason for Recall

The seal on the dressing pouch may open during shipping and sterility of the dressing may be compromised.

Firm Action

The firm initiated the recall by letter and phone calls on September 21, 2004.

Root Cause

Other

Distribution Pattern

The product was distributed to hospitals and clinics nationwide. The product was also shipped to the following foreign countries: Australia, Austria, Belgium, Canada, Denmark, France, Germany, Greece, Qatar, Phillipines, United Arab Emirates, Ireland, Italy, Netherlands, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K032310MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATSKinetic Concepts, Inc. · 2003-10-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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