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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Device

Datascope Corporation: 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.; 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.

Agency Publication Date: June 6, 2018
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Affected Products

Product: Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET, Part Number 701054588

Batch Number 3000020069, UDI Code 10607567203300; Batch Number 3000021675, UDI Code 10607567203300

Lot Numbers:
Number
10607567203300
Number
10607567203300
Product: Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 15801 Neonatal Special, Part Number 701055490

Batch Number 3000020957, UDI Code 10607567203522

Lot Numbers:
Number
10607567203522
Product: Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Part Number 701064992

Batch Number 3000018640, UDI Code 10607567205373; Batch Number 3000020516, UDI Code 10607567205373

Lot Numbers:
Number
10607567205373
Number
10607567205373

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 80086
Status: Resolved
Manufacturer: Datascope Corporation
Manufactured In: United States
Units Affected: 3 products (19 total kits; 194 total kits; 19 total kits)

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.