Device product
SW-2008 Snuggle Warm Sterile Cardiac Connective Warming Blanket; used with the Equator Convective Warmer, are intended for thermal regulation of a patient's temperture and are designed to prevent hypothermia and/ or reduce cold discomfort during and after surgical procedures.
Z-1650-2014
Product summary
- Event
- Event 68094
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2120 devices
- Official record key
device-enforcement:Z-1650-2014
Official wording
Reason: The hose could separate from the blanket.
Code information: Lot: 1006733, 2474599, 2488138, 2523531, 2536250, 2558180, 2563033, 2564447, 2564448, 2615712
Distribution pattern: Worldwide Distribution Including the States of CA, IL, KY, MS, NC, TN, TX, WA, WI and the Countries of BH, DE, NO, RU
Derived failure modes
-
Unknown
The hose could separate from the blanket.