Z-2871-2017 Class II Terminated
FDA device recall Z-2871-2017 was initiated by Sorin Group USA, Inc. on June 9, 2017 and is designated Class II. Reason for recall: Identification of excess plastic on the tip of the cannula. The recall status is terminated (terminated November 9, 2023). Affected quantity: 105,770 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 16, 2017
- Initiation Date
- June 9, 2017
- Termination Date
- November 9, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 105,770 units
Product 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.
Reason for Recall
Identification of excess plastic on the tip of the cannula.
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of : AR, AZ, CA, GA, IL, IN, KS, MI, MN, MO, NC, NE, NY, OK, PA, SD, TX, & VA. and foreign countries of: Canada, Iran, Mexico, & New Zealand.
Code Information
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.