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Terumo Cardiovascular Systems Corporation Recall: Battery, 220V (Includes charger and conn

Terumo Cardiovascular Systems Corporation Recall: Battery, 220V (Includes charger and conn is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Terumo Cardiovascular Systems Corporation; Product: Battery, 220V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicate

Recalling firmTerumo Cardiovascular Systems Corporation
ProductBattery, 220V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
Reason for recallTerumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2004 of various malfunctions of the battery backup system for the Sarns" Centrifugal System. The reports can be broadly categorized as follows: " Failure to charge " Failure to hold charge " Failure to operate In the most severe case, a battery malfunction could result in an unexpected loss of arterial flow. In
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusTerminated
DistributionWorldwide distribution: USA including: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, UT, VA, WA, WI, and WV. Puerto Rico and internationally to: ALEXANDRIA, ARGENTINA, AUSTRALIA, AUSTRIA, BA
Recall initiated20120925
Recall numberZ-0050-2013
Categorydevice
StateMI
CountryUnited States

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