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Terminated

V.A.C. ATS Canister with Gel (500 mL), Part #M6275063/10.S, distributed by Kinetic Concepts, Inc., San Antonio, TX. Product is labeled as STERILE.

FDA Recall Z-0379-06 · Posted 2006-01-11

Recalling FirmKinetic Concepts, Inc
Recall StatusTerminated
Product CodeJCX
Date Initiated2005-09-16
Date Terminated2006-02-21
Product Quantity64 cartons.

Reason for Recall

Possible mislabeling of shipping cartons.

Firm Action

All hospitals and nursing homes contacted via letter and by phone.

Root Cause

Other

Distribution Pattern

Product distributed nationwide to hospitals and nursing homes in the following states: AL, AZ, CA, CO, CT, FL, IL, IN, KY, MA, NC, NY, OK, PA, SC, and TX.

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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