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Datascope Corporation Recall 90684

Description: MEGA 8Fr 50cc Intra-Aortic Balloon Catheter

Datascope Corporation Recall 90684 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1685-2022
Event ID90684
Event DescriptionMEGA 8Fr 50cc Intra-Aortic Balloon Catheter
Product TypeDevices
DistributionAwaiting domestic distribution. Foreign: Australia, Belgium, Canada, Czech Republic, France, Germany, Hong Kong, Iceland, Ireland, Italy, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.
Quantity10,427 units
Recall ReasonCertain lots containing undersized dilator.
Device Classification20220914
Device Code InfoCode information reads "UDI-DI, Lot No., Finished Goods Part No.": 10607567109619, 3000184437, 0684-00-0296-01U; 10607567107301, 3000171501, 0684-00-0498-01; 10607567107301, 3000183312, 0684-00-0498-01; 10607567107301, 3000183313, 0684-00-0498-01; 10607567107301, 3000186654, 0684-00-0498-01; 10607567107301, 3000186655, 0684-00-0498-01.
Center Classification Date20220908
Recall Initiation Date20220805
Recalling FirmDatascope Corporation
Initial Notification Letter
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