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U.S. Department of Health and Human Services

Class 2 Device Recall Sarns Twostage Venous Return Cannulae

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 Class 2 Device Recall Sarns Twostage Venous Return Cannulaesee related information
Date Initiated by FirmMay 23, 2014
Date PostedJuly 23, 2014
Recall Status1 Terminated 3 on February 24, 2015
Recall NumberZ-2100-2014
Recall Event ID 68404
510(K)NumberK770431 K920902 
Product Classification Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
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.
Code Information Part No. 4442, Lot #:, 0646528, 0649147, 0649840, 0654076, 0662223, 0678729; Part No. 14992, Lot #: 0646475, 0649160, 0655317, 0659466, 0666649, 0672081, 0675675, 0681806, 0686885; Part No. 4443, Lot #: 0649883, 0660672 & Part No. 15949, Lot #: 0646530, 0661896, 0667259, 0674784, 0683631.
Recalling Firm/
Manufacturer
Terumo Cardiovascular Systems Corporation
6200 Jackson Rd
Ann Arbor MI 48103-9586
For Additional Information Contact
800-521-2818
Manufacturer 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
FDA Determined
Cause 2
Process control
ActionTerumo sent an Urgent Medical Device Recall letters dated June 27, 2014 to their customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to 1. Review this Medical Device Recall notice, 2. Assure that all users in your institution have received notice of this issue and remove any affected units from use, 3. Fill out the Product Tracking Sheet (enclosed), indicating the number of affected units at your institution and fax to 1-877-907-7509 or email to terumo4967@stericycle.com. 4. Complete the Packing Slip (enclosed) and follow the packing instructions to return the affected product, and 5. Terumo CVS will issue credit once the affected units are returned. For questions call Terumo CVS c/o Stericycle 1-866-629-6181.
Quantity in Commerce6,720 units
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, Belgium, Canada, Chile, Japan, Malaysia, Mexico, Singapore, Taiwan, Thailand, United Arab Emirates (UAE) & United Kingdom.
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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