—#128126

Product

Sarns Soft-Flow Aortic Cannulae 6.0mm, 7mm & 8mm angled and straight tip, suture bulb with or without Luer and/or Xcoating Product Usage: The 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.

FDA product code: DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K934127
Affected lot / code info: Part No. 7071, Lot #: 0658575, 0662312, 0666660, 0670324, 0670948, 0682566, 0686889, 0689725, 0695466, 0702123, 689725R; Part No. 7072, Lot #: 0658572, 0662311, 0670325, 0686126, 0687466, 0694421, 0702124, 694421R, 694445R; Part No. 7072X, Lot #: 0662871, 662871R, 684785R; Part No. 7080, Lot #: 0661085, 0670671, 0675676, 0687168, 0694423, 0696700, 0702127, 0711833, 694423R; Part No. 5767, Lot #: 0652211, 0661105, 0664361, 0670323, 0675826, 0677192, 0684996, 0685122, 0685123, 0689787, 0697471, 0708188, 0708770, 667914N, 689787R, 695467R; Part No. 5761, Lot #: 0650494, 0653427, 0661106, 0667066, 0668960, 0670940, 0672074, 0677795, 0678216, 0683309, 0685666, 0687798, 0689724, 0694428, 0696206, 0698338, 0703836, 0704646, 0708187, 0708767, 694428R; Part No. 5761X, Lot #: 0653824, 0660674, 0668570, 0674464, 0683051, 0686891, 686891R; Part No. 5767X, Lot #: 0662430, 0670967, 670967R; Part No. 6392, Lot #: 0648090, 0653418, 0659107, 0661101, 0664539, 0676371, 0677191, 0677794, 0685662, 0685663, 0685664, 0689718, 685664R, 689718R, 697473R; Part No. 6394, Lot #: 0650838, 0659106, 0661098, 0670945, 0674474, 0678011, 0685489, 0689720, 0696207, 0702122, 689720R; Part No. 5842, Lot #: 0654074, 0656644, 0671750, 0681809, 0688003, 0695986, 0710040, 688003R; Part No. 5798, Lot #: 0649217, 0656439, 0660663, 0662070, 0670425, 0677301, 0686890, 0688490, 0711274, 0711827, 688490R; Part No. 6393, Lot #: 684774R; Part No. 5768, Lot #: 0649874, 0654075, 0659017, 0662733, 0669800, 0670941, 0675738, 0677971, 0685665, 0687801, 0695468, 0708190, 687801R; Part No. 5762, Lot #: 0647163, 0650493, 0653424, 0659018, 0668571, 0670937, 0673175, 0674263, 0677300, 0678059, 0686324, 0689721, 0694413, 0702121, 0708189, 0708776, 694413R, 696147R; Part No. 5762X, Lot #: 0649168, 0661605, 696146R; Part No. 5768X, Lot #: 0661175, 0673743, 0677012, 677012R, 695469R; Part No. 6384, Lot #: 0649216, 0658580, 0666662, 0670943, 0674472, 0680716, 0687537, 0709686; Part No. 6386, Lot #: 0649585, 0653419, 0666613, 0668004, 0670938, 0676537, 0681103, 0687538, 0688901, 0709688, 688901R; Part No. 5843, Lot #: 0658532, 0677970, 0683959, 0687467, 0701580, 0710041, 687467R, 691572R. Part No. 5841, Lot #: 0660648, 0674761, 0677302, 0702132, 0711246, 690085R; Part No. 6387, Lot #: 0660256, 0695470, 660256R & Part No. 6385, Lot #: 653813.

Why it was recalled

During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications

Root cause (FDA determination)

Process control

Action the firm took

Terumo 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.

Recalling firm

Firm: Terumo Cardiovascular Systems Corporation
Address: 6200 Jackson Rd, Ann Arbor, Michigan 48103-9586

Distribution

Distribution pattern: 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, Belgium, Canada, Chile, Japan, Malaysia, Mexico, Singapore, Taiwan, Thailand, United Arab Emirates (UAE) & United Kingdom.

Timeline

Recall initiated: 2014-05-23
Posted by FDA: 2014-07-23
Terminated: 2015-02-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #128126. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.