FDAFDA · Food and drugs·Recall number Z-2210-2012
Maquet Getinge Group Pediatric Arterial Cannula Maquet Cardiopulmonary AG Kehler Strabe 31 76437 Rastatt Germany Phone +49 7222 932-0 Fax: +49 7222 932-1888 info.cp@maquet.com www.maquet.com Used to introduce blood and sterile solution to the circulation system during extracorporeal circulation procedures
Published August 22, 2012 · Recall initiated: May 29, 2012
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
Certain pediatric arterial cannulas may have limited flexibility due to an increased length of the "hardened" cannula tip.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Maquet Inc.
- Distributor
- Worldwide Distribution - USA including MI, MN and Internationally
- Lot
- 510k023251 US Catalog Number 161412 Batch Number 92048923 Foreign Catalog number 161412 Batch number 92048923 Catalog number 161412 Batch number 92051578
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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