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Terumo Cardiovascular Systems Corporation Recall: Sarns Two-stage Venous Return Cannulae 3

Terumo Cardiovascular Systems Corporation Recall: Sarns Two-stage Venous Return Cannulae 3 is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Terumo Cardiovascular Systems Corporation; Product: Sarns Two-stage Venous Return Cannulae 32/40 & 36/51 Fr with 1/2" & 3/8" flare or connector Pro

Recalling firmTerumo Cardiovascular Systems Corporation
ProductSarns Two-stage Venous Return Cannulae 32/40 & 36/51 Fr with 1/2" & 3/8" flare or connector Product Usage: The Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava.
Reason for recallDuring an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusTerminated
DistributionWorldwide 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 initiated20140523
Recall numberZ-2100-2014
Categorydevice
StateMI
CountryUnited States

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