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U.S. Department of Health and Human Services

Class 2 Device Recall Sarns Malleable Dualstage Venous Return Cannulae

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 Class 2 Device Recall Sarns Malleable Dualstage Venous Return Cannulaesee related information
Date Initiated by FirmMarch 03, 2014
Date PostedMarch 19, 2014
Recall Status1 Terminated 3 on August 12, 2014
Recall NumberZ-1220-2014
Recall Event ID 67598
510(K)NumberK920902 
Product Classification Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
ProductSarns Malleable Dual-stage Venous Return Cannulae, 32/40 Fr with 1/2" connector, 15" (38 cm) long 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.
Code Information Catalog Number 4935
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corporation
6200 Jackson Rd
Ann Arbor MI 48103-9586
For Additional Information Contact
734-741-6173
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionTerumo 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.
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DWF
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