Sleeve, Limb, Compressible

SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller

Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.

Kendall SCD Comfort Sleeves

Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.

Kendall SCD Blended Comfort

Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.

REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,<12", Rx Only Non-Sterile

Through complaint surveillance, it was identified that reprocessed Deep vein thrombosis (DVT) Compression Sleeves may be mislabeled and/or mispackaged.

ArjoHuntleigh Flowtron ACS900, medical pump, software V1.099

Reports of the device failure involving delivering continuous pressure to the calf garment and not deflating as intended, without triggering an alarm.

VenaFlow Elite 30B-B and 30BI-B

DJO, LLC has recently identified a product safety issue with the battery assembly for the VenaFlow 30B-B and 30 BI-B products. There is a potential for battery leakage which could result in thermal meltdown (fire).

- Calf Garment Standard Ref. L501-M Lot 122549, 122985

The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.

STRYKER Sustainability Solutions, AC Power Adaptor for Restep Deep Vein Thrombosis (DVT) System, an external compression system. PUMPKIT (Pump Kit), and RSP159

Reports that the AC Power Adaptor may not operate due to wires coming loose in the unit.

Flowtron Trio DVT Pump; an Rx intermittent pneumatic compression deep vein thrombosis pump; ArjoHuntleigh AB, Eslov, Sweden; Model 512003; a non-invasive prophy

The Flowtron Trio DVT Pump has been marketed without proper FDA Approval.

ActiveCare +SFT

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.