Reported Jul 20, 2016 · Terminated
AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (part numbers NA-55X7 and NA-55X8)…
Sorin Group USA, 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: Sorin Group USA, Inc. · 14401 W 65th Way · Arvada, CO · 80004-3503
Is this the product you have?
- AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (part numbers NA-55X7 and NA-55X8) Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery. The cannula consists of varying lengths of non-wire reinforced (flexible) polyvinyl chloride tubing that terminates in an angled tip. These devices come in direct contact with the central circulatory system but they are not intended to control, diagnose, monitor or correct a defect.
- Lot codes and dates
- Lots
150560001715056000181506500005150920007815131001121513900027151390002815147000451516600192151680012615178000041519500037152010004915201000501520900031152090003315216001261523000093152360012015251000231525800026152650003215265000331526500034152650007215272000501527200051152720005215278001631529300026152930002715293000281533500033153420003416019000271601900028
- Lots
- Amount recalled
- 5740
Where it was sold
Why it was recalled
Sorin Group USA is recalling Aortic Arch Cannulae (part numbers NA-55X7 and NA-55X8) because the distal end may be less than specified. The defective cannula are showing an angle that is about 15-20 degrees instead of approximately 45 degrees.
This product could cause temporary or reversible health problems — stop using it.
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