Recall Z-0386-2012 ยท JOW Sleeve, Limb, Compressible
Medical Compression Systems
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
| Date | Jan 11, 2012 (initiated Aug 28, 2011) |
| Status | Terminated |
| Reason | 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 | 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 maya@mcsmed.com; even if they do not have any such devices. The letter also states that within 15 days from the email, they will receive instructi |
| Quantity | 551 units |
| Distribution | Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060146 | ACTIVECARE ++ SYSTEM Medical Compression Systems (Dbn) , Ltd., Mar 8, 2006 |