Reported Aug 22, 2012 · Terminated
Maquet Getinge Group Pediatric Arterial Cannula Maquet Cardiopulmonary AG Kehler Strabe 31 76437 Rastatt Germany Phone…
Maquet Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Maquet Inc. · 45 Barbour Pond Drive · Wayne, NJ · 07470
Is this the product you have?
- 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
- Lot codes and dates
- 510k023251 US Catalog Number 161412 Batch Number 92048923 Foreign Catalog number 161412 Batch number 92048923 Catalog number 161412 Batch number 92051578
- Amount recalled
- 20 devices US; 122 devices foreign
Where it was sold
Why it was recalled
Certain pediatric arterial cannulas may have limited flexibility due to an increased length of the "hardened" cannula tip.
This product could cause temporary or reversible health problems — stop using it.
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