Sarns Dual-stage Venous Return Cannulae, 32/40 Fr with 1/2" flare The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
FDA Recall Z-1223-2014 · Posted 2014-03-19
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Recalling FirmTerumo Cardiovascular Systems Corporation
Recall StatusTerminated
Product CodeDWF
Date Initiated2014-03-03
Date Terminated2014-08-12
Reason for Recall
During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae.
Firm Action
Terumo sent an Urgent Medical Device Recall letter dated March 3, 2014, to all affected consignees. The letter included the reason for removal, potential hazards, and customer instructions. Terumo CVS advised users to stop using the affected devices and return any unused product on hand. Questions or concerns were directed to Terumo CVS Customer Service: 1-800-521-2818 M-F, 8am-6pm.
For questions regarding this recall call 734-741-6173.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution - USA including CA, CT, FL, GA, IL, IN, LA, MI, MN, MO, NC, NY, PA, TN, TX, and Internationallly to United Arab Emirates (UAE), Taiwan, Thailand, Malaysia, Belgium, Japan, Mexico, and Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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