FDAFDA · Food and drugs·Recall number Z-1685-2022
MEGA 8Fr 50cc Intra-Aortic Balloon Catheter
Published September 14, 2022 · Recall initiated: August 5, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Certain lots containing undersized dilator.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Datascope Corporation
- Distributor
- Awaiting 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.
- Lot
- Code 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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