Z-0386-2012

ActiveCare +SFT Medical Compression Systems OR Aqiva, IL Intended for use in: Preventing deep Vein...

Name: Z-0386-2012 ActiveCare +SFT Medical Compression Systems OR Aqiva, IL Intended for use in: Preventing deep Vein...
Creator: Medical Compression Systems
Published: 2011-08-28
License: https://open.fda.gov/license/

Medical Compression Systems / initiated 2011-08-28 / Terminated / root cause: design

FDA source

Medical Compression Systems began a recall of ActiveCare +SFT Medical Compression Systems OR Aqiva, IL Intended for use in: Preventing deep Vein Thrombosis; Enhancing blood circulation; Diminishing... on 2011-08-28. The reason FDA records is "This voluntary field action is being undertaken because MCS has received a limited number of reports involving the use of a non-MCS AC/DC adaptor with the ActiveCare DVT and ActiveCare+S.F.T. devices. The firm found...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0386-2012
Status: Terminated
Initiated: 2011-08-28
Posted: 2012-01-11
Terminated: 2012-07-11
Recalling firm: Medical Compression Systems
Product: ActiveCare +SFT Medical Compression Systems OR Aqiva, IL Intended for use in: Preventing deep Vein Thrombosis; Enhancing blood circulation; Diminishing post-operative pain and swelling; Reducing wound healing time; treatment and assistance in healing of stasis dermatitis, venous stasis ulcers and diabetic leg ulcers; Treatment of chronic venous insufficiency and; Reducing edema
Product code: JOW Sleeve, Limb, Compressible
Reason for recall: This voluntary field action is being undertaken because MCS has received a limited number of reports involving the use of a non-MCS AC/DC adaptor with the ActiveCare DVT and ActiveCare+S.F.T. devices. The firm found that an ActiveCare+S.F.T device might cease to work if connected to a non-MCS AC/DC adaptor with a higher nominal voltage. As specified in each product's User Manual the ActiveCare+S.
Root cause tag: design
FDA root cause: Device Design
Action: Medical Compression Systems (DBN) Ltd, sent out "VOLUNTARY FIELD ACTION" letters dated September 15, 2011 to all affected customers. The letter included description of the device and problem. Customers were instructed to check their inventory and make a list of serial numbers of all applicable ActiveCare+S.F.T. and ActiveCare DVT devices in their inventory, include the list on the attached excel file (Field Action Verification Form) and email to [email protected]; even if they do not have any such devices. The letter also states that within 15 days from the email, they will receive instructions for the next steps. In addition, the letter stated -YOU MAY CONTINUE TO USE THE ActiveCare+S.F.T. DEVICES WHILE AWAITINGTHE INSTALLATION OF THE OVP. In case you have questions or you need any assistance, you can contact the firm at (317) 485-7887 or e-mail to: [email protected] or [email protected].
Quantity in commerce: 551 units
Distribution: Nationwide distribution.
Product codes and lots: Device Catalog Number A502B-0001-01 and A502B-0002-01

Product code JOW

K060146Class IIActivecare ++ SystemMedical Compression Systems (Dbn) , Ltd. / cleared 2006-03-08

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)