FDAFDA · Food and drugs·Recall number Z-1935-2016
MEGA¿ 7.5Fr. 30cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ MEGA¿ 7.5Fr. 40cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ MEGA¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ MEGA¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit, STATLOCK¿ & APA
Published June 15, 2016 · Recall initiated: May 13, 2016
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
It was discovered during post-quarantine packaging on 2/16/2016 that the IFU for the STATLOCK Sheath Stabilization device for Percutaneous Sheath Introducer (Vendor PN 2403097-1405R) was erroneously packaged with the Mega and Sensation Plus IAB Catheter Kits instead of the IFU for the STATLOCK Catheter Stabilization device for IAB catheters (Vendor PN 24030905-1406R).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Datascope Corporation
- Distributor
- Worldwide Distribution.
- Lot
- (PN 0684-00-0294-01U) (PN 0684-00-0294-02U) (PN 0684-00-0295-01U) (PN 0684-00-0295-02U) (PN 0684-00-0296-01U)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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