Terumo Recalls Sarns Soft-Flow Aortic Cannulae Due to Fiber Particulate
Terumo CVS is recalling Sarns Soft-Flow Aortic Cannulae because in-process inspections found loose fiber particulate exceeding specifications.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text does not report any illnesses, injuries, or hospitalizations, and the hazard is identified as a deviation from specifications (loose fiber particulate) rather than a confirmed high-risk pathogen or structural failure causing harm.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling Sarns Soft-Flow Aortic Cannulae in 6.0mm, 7mm, and 8mm sizes. The recall involves 132,250 units of the devices, which are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
The recall was initiated after an in-process inspection identified the presence of loose fiber particulate that exceeded finished product specifications. The affected products were distributed worldwide, including nationwide in the United States and in several other countries such as Australia, Canada, and the United Kingdom.
Healthcare facilities should stop using the affected lots and contact Terumo CVS for further instructions. Specific lot numbers and part numbers are listed in the official recall documentation.
The recalled product
- 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 indic
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Part of a larger recall action
This product is one of 13 recalled by Terumo Cardiovascular Systems Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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