Device product

LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group

Z-2568-2014

August 11, 2014

Class III

Product summary

Firm: Datascope Corporation
Event: Event 69072
Status: Terminated
Classification: Class III
Quantity: one unit
Official record key: device-enforcement:Z-2568-2014

Official wording

Reason: During label reconciliation a duplicate serial number label was detected to be printed for the LINEAR 7.5 FR 40 cc Intra-Aortic Balloon Catheter.

Code information: Part Number - 0684-00-0480-01U

Distribution pattern: US Distribution to TX.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

During label reconciliation a duplicate serial number label was detected to be printed for the LINEAR 7.5 FR 40 cc Intra-Aortic Balloon Catheter.