Terumo CPB Catheter Kit Recalled for Loose Fiber Particulate
Terumo CVS is recalling 125 CPB Catheter Kits 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 a particulate specification deviation identified during inspection, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 125 units of CPB Catheter Kits. The product is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava.
The recall was initiated after an in-process inspection identified the presence of loose fiber particulate that exceeded finished product specifications. The affected units include Part No. 80003-02 (Lot #s PG11, QC11, QL09) and Part No. 80002-03 (Lot #s PG11, QL09).
The products were distributed nationwide in the United States and in several international countries, including Australia, Belgium, Canada, and the United Kingdom. Healthcare facilities should stop using the affected lots and contact the manufacturer for further instructions.
The recalled product
- Product
- CPB Catheter Kit Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava.
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Affected units
- 125
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 (5)
- Part No. 80003-02
- Lot #: PG11
- QC11
- QL09 & Part No. 80002-03
- QL09
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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