Sarns Soft-Flow Aortic Cannulae 6.0mm recall: Particulate Matter
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…
Why was Sarns Soft-Flow Aortic Cannulae 6.0mm recalled?
During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- 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…
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Quantity
- 132, 250 units
- Distribution
- 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.
- Recall date
- July 30, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)