Reported Jul 30, 2014 · Terminated
Sarns D4 Aortic Arch Cannulae 6.0mm, 7mm & 8mm angled and straight tip with or without side holes and/or luer Product…
Terumo Cardiovascular Systems Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Terumo Cardiovascular Systems Corporation · 6200 Jackson Rd · Ann Arbor, MI · 48103-9586
Is this the product you have?
- Sarns D4 Aortic Arch Cannulae 6.0mm, 7mm & 8mm angled and straight tip with or without
- side holes and/or luer Product UsageThe Sarns 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
- Lot codes and dates
13 of 13 products
Products covered by this recall Model / number Product as published 165269Lot #: 0649648, 0652316, 0653402, 0659824, 0678725, 0682564 9482Lot #: 0653227, 0656440, 0673777 4344Lot #: 0645166, 0653856, 0673024 9485Lot #: 654068 9486Lot #: 649867 4400Lot #: 0650491, 0659436, 0669133, 0674461 165267Lot #: 0654562, 0672209, 0676284, 0678213 165266Lot #: 0658973, 0661133, 0667798, 0675018, 0678084 9483Lot #: 0649709, 0653442, 0655043 4460Lot #: 0667803, 0675761, 0677655 165765Lot #: 677007 165265Lot #: 0652644, 0659820, 0674746, 0683956 9484Part No. 165264, Lot #: 0646481, 0650489, 0653235, 0668894, 0676282, 0681876, 0683955 & , Lot #: 0649158, 0655040, 0660676. - Amount recalled
- 7,460 units
This recall covers 13 products
The agency filed one notice per product. You are reading one of them; the other 12 are below.
Where it was sold
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
This product could cause temporary or reversible health problems — stop using it.
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