FDAFDA · Food and drugs·Recall number Z-2568-2014
LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group
Published September 10, 2014 · Recall initiated: August 11, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Datascope Corporation
- Distributor
- US Distribution to TX.
- Lot
- Part Number - 0684-00-0480-01U
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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