Datascope Recalls Maquet Cardiopulmonary Bypass Custom Tubing Kits
Datascope Corporation is recalling 19 Maquet Cardiopulmonary Bypass Custom Tubing kits due to a potential cuvette failure that causes monitor errors.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as unlikely to cause adverse health consequences. The source text describes a monitor error message resulting from a component failure, with no reported injuries or illnesses.
Plain-English summary
Datascope Corporation is recalling 19 units of the Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Part Number 701064992. The recall involves specific batch numbers 3000018640 and 3000020516, both associated with UDI Code 10607567205373.
The recall was initiated because of a potential problem with the cuvette component. If the cuvette fails, it causes an error message on the monitor display reading 'H/S DISCONNECT AT CUVETTE.' The source text does not report any illnesses, injuries, or deaths associated with this defect.
The affected products were distributed to facilities in Alabama, Oregon, and Texas. Healthcare providers and consumers should stop using the affected kits and contact Datascope Corporation for further instructions.
The recalled product
- Product
- Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Part Number 701064992
- Manufacturer
- Datascope Corporation
- Affected units
- 19
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 (3)
- Batch Number 3000018640
- UDI Code 10607567205373
- Batch Number 3000020516
Distribution
Part of a larger recall action
This product is one of 3 recalled by Datascope 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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