Datascope Cardiopulmonary Bypass Tubing Kit Recalled for Cuvette Failure
Datascope is recalling 19 cardiopulmonary bypass tubing kits due to a potential cuvette failure that causes monitor error messages.
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 typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Datascope Corporation is recalling 19 units of the Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET, Part Number 701054588. The recall involves specific batch numbers 3000020069 and 3000021675, both associated with UDI Code 10607567203300.
The recall is issued 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 affected products were distributed to facilities in Alabama, Oregon, and Texas.
Healthcare facilities should stop using the affected kits and contact Datascope Corporation for further instructions. This recall is classified as Class III by the FDA, indicating the product is unlikely to cause adverse health consequences.
The recalled product
- Product
- Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET, Part Number 701054588
- Manufacturer
- Datascope Corporation
- Hazard
- 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 3000020069
- UDI Code 10607567203300
- Batch Number 3000021675
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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