Datascope Corporation: Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Part Number 701064992

Is my product affected?

Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Part Number 701064992

• UPC 10607567205373

Check against the official notice below — it lists the full affected range.

What happened

Datascope Corporation is recalling Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID (Part Number 701064992) due to a potential problem with the cuvette that could cause a failure and trigger an error message reading "H/S DISCONNECT AT CUVETTE" on the monitor display. A total of 19 kits were distributed across Alabama, Oregon, and Texas.

The affected products are identified by two batch numbers: 3000018640 and 3000020516, both with UDI Code 10607567205373. The recall record does not specify a remedy or action for consumers to take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

There is a potential problem with the cuvette where failure of the cuvette would cause an error message on the monitor display of H/S DISCONNECT AT CUVETTE.

Details from the source

Reason for recall: There is a potential problem with the cuvette where failure of the cuvette would cause an error message on the monitor display of H/S DISCONNECT AT CUVETTE. Distribution: The products were distributed to the following US states: AL, OR, and TX. Quantity: 19 total kits Lot/code info: Batch Number 3000018640, UDI Code 10607567205373; Batch Number 3000020516, UDI Code 10607567205373

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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