FDA-Device2014-09-10Class III

LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group

Datascope Corporation
Hazard

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.

Sold states
US Distribution to TX.
Affected count
one unit
Manufactured in
15 Law Dr, Fairfield, NJ, United States
Products
LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2568-2014

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