Reported Aug 16, 2017 · Terminated
Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile Product Usage: The Aortic Arch Cannulae are…
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?
- Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only
- Sterile Product UsageThe Aortic Arch Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery
- Lot codes and dates
Model No. NA-1116NA-1118NA-1126NA-1136NA-1206NA-1207NA-1208NA-1316NA-1327NA-1337NA-1338RA-1117RA-1126RA-1127RA-1128ARA-1136RA-1137ARA-1137RA-1138RA-1206Lot No. 1407000078 to 1705200165S140979 to S141841
- Amount recalled
- 105,770 units
Where it was sold
Why it was recalled
Identification of excess plastic on the tip of the cannula.
This product could cause temporary or reversible health problems — stop using it.
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