Terumo Cardiovascular Systems Corporation Recall: Sarns D4 Aortic Arch Cannulae 6.0mm, 7mm
Terumo Cardiovascular Systems Corporation Recall: Sarns D4 Aortic Arch Cannulae 6.0mm, 7mm is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Terumo Cardiovascular Systems Corporation; Product: Sarns D4 Aortic Arch Cannulae 6.0mm, 7mm & 8mm angled and straight tip with or without side hol
| Recalling firm | Terumo Cardiovascular Systems Corporation |
|---|---|
| Product | Sarns D4 Aortic Arch Cannulae 6.0mm, 7mm & 8mm angled and straight tip with or without side holes and/or luer Product Usage: The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. |
| Reason for recall | During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Worldwide Distribution - US (nationwide) in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV & WY and the countries of : Australia, Bel |
| Recall initiated | 20140523 |
| Recall number | Z-2094-2014 |
| Category | device |
| State | MI |
| Country | United States |
$29/mo
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