Agency classClass IIIOur severity:Low FDA (Devices)·Z-2105-2018·Announced 2018-06-13

Datascope Recalls Maquet Cardiopulmonary Bypass Custom Tubing Kits

Datascope is recalling 194 Maquet Cardiopulmonary Bypass Custom Tubing kits due to a potential cuvette failure that triggers a monitor error.

The agency’s classification

FDA (Devices): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because the product is unlikely to cause adverse health consequences.

Plain-English summary

Datascope Corporation is recalling 194 units of the Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 15801 Neonatal Special, Part Number 701055490. The recall is associated with Batch Number 3000020957 and UDI Code 10607567203522. The affected products were distributed to facilities in Alabama, Oregon, and Texas.

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.

Healthcare facilities that have received these specific kits should stop using them and contact Datascope Corporation for further instructions on return or replacement. This recall is classified as Class III by the FDA, indicating that the product is not likely to cause adverse health consequences.

The recalled product

Product: Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 15801 Neonatal Special, Part Number 701055490
Manufacturer: Datascope Corporation
Category: Medical Device — Cardiopulmonary Bypass
Hazard: component-failure
Affected units: 194

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 (2)

Batch Number 3000020957
UDI Code 10607567203522

Distribution

Distributed in 3 states:

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.

See all 3 products in this recall →

Same manufacturer · Datascope Corporation

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Same hazard · component failure