Z-0379-06

V.A.C. ATS Canister with Gel (500 mL), Part #M6275063/10.S, distributed by Kinetic Concepts, Inc., San...

Name: Z-0379-06 V.A.C. ATS Canister with Gel (500 mL), Part #M6275063/10.S, distributed by Kinetic Concepts, Inc., San...
Creator: Kinetic Concepts, Inc
Published: 2005-09-16
License: https://open.fda.gov/license/

KCI USA, Inc. / initiated 2005-09-16 / Terminated / root cause: labeling and UDI

FDA source

Kinetic Concepts, Inc began a recall of 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 on 2005-09-16. The reason FDA records is "Possible mislabeling of shipping cartons". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0379-06
Status: Terminated
Initiated: 2005-09-16
Posted: 2006-01-11
Terminated: 2006-02-21
Recalling firm: KCI USA, Inc.
Product: 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.
Product code: JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
Reason for recall: Possible mislabeling of shipping cartons.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: All hospitals and nursing homes contacted via letter and by phone.
Quantity in commerce: 64 cartons.
Distribution: 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.
Product codes and lots: Lot #08150506M

Product code JCX

K032310Class IIMini V.a.c., V.a.c. Freedom, V.a.c. AtsKinetic Concepts, Inc. / cleared 2003-10-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)