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Recall Observatory FDA recall evidence

Device product

CP5 centrifugal pump system Product Usage: The Stockert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.

Z-0857-2014

December 04, 2013

Class II

Product summary

Firm
Sorin Group Deutschland GmbH
Event
Event 67199
Status
Terminated
Classification
Class II
Quantity
75
Official record key
device-enforcement:Z-0857-2014

Official wording

Reason: Sorin is initiating a field correction on S5/C5 Heart-lung machine and CP5 centrifugal pump system due to reports of pump speed control knob failures resulting in no response.

Code information: Item Number: 60-02-60

Distribution pattern: Worldwide Distribution - US (Nationwide) and PR; and Internationally to:BE, ES, FI, GB, NL, SE, AR, AT, AU, CA, CH, CN, CR, EG, HK, ID, JO, JP, KR, KW, LB, LY, MM, PL, RO, RS, RU, SG. TH, TN, TR, TW, UA, VN, and ZA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Sorin is initiating a field correction on S5/C5 Heart-lung machine and CP5 centrifugal pump system due to reports of pump speed control knob failures resulting in no response.