Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile Product Usage: The Aortic Arch Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model No. NA-1116, NA-1118, NA-1126, NA-1136, NA-1206, NA-1207, NA-1208, NA-1316, NA-1327, NA-1337, NA-1338, RA-1117, RA-1126, RA-1127, RA-1128A, RA-1136, RA-1137A, RA-1137, RA-1138, RA-1206; Lot No. 1407000078 to 1705200165, S140979 to S141841.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Sorin Group USA, Inc.
- Reason for Recall:
- Identification of excess plastic on the tip of the cannula.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile Product Usage: The Aortic Arch Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Product Codes/Lot Numbers:
Model No. NA-1116, NA-1118, NA-1126, NA-1136, NA-1206, NA-1207, NA-1208, NA-1316, NA-1327, NA-1337, NA-1338, RA-1117, RA-1126, RA-1127, RA-1128A, RA-1136, RA-1137A, RA-1137, RA-1138, RA-1206; Lot No. 1407000078 to 1705200165, S140979 to S141841.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2871-2017
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