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Recall Observatory FDA recall evidence

Device product

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.

Z-2871-2017

June 09, 2017

Class II

Product summary

Firm
Sorin Group USA, Inc.
Event
Event 77699
Status
Terminated
Classification
Class II
Quantity
105,770 units
Official record key
device-enforcement:Z-2871-2017

Official wording

Reason: Identification of excess plastic on the tip of the cannula.

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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Identification of excess plastic on the tip of the cannula.