Maquet Medical Systems USA: 1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.; 1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory s sterile

Agency Publication Date: May 26, 2023

Affected Products

Product: QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 50000-USA 701067891 HMO 51000-USA 701067895

Model Item no. UDI-DI HMO 50000-USA 701067891 4058863019055 HMO 51000-USA 701067895 4058863019185 All lots

Product: HMOD 70000-USA/QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067840

UDI-DI: 04058863019000 All lots

Product: BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass Item no. 701067859

UDI-DI: 04058863019024 All lots

Product: BEQ-HMO 50000-USA/ QUADROX-i Small, Oxygenator used during cardiopulmonary bypass Item no. 701067905

UDI-DI: 04058863019079 All lots

Product: QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 70000-USA 701067820 HMO 71000-USA 701067823

Model Item no. UDI-DI HMO 70000-USA 701067820 4058863019147 HMO 71000-USA 701067823 4058863017341 All lots

Product: BEQ-HMO 71000-USA /QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067829

UDI-DI: 4058863017372 All lots

Product: QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 10000-USA 701070412 HMO 11000-USA 701070416

Model Item no. UDI-DI HMO 10000-USA 701070412 4058863154473 HMO 11000-USA 701070416 4058863154558 All lots

Product: QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA 701070388

Model Item No. UDI-DI HMO 30000-USA 701070384 4058863153681 HMO 31000-USA 701070388 4058863154299 All lots

Product: Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA 701070445

Model Item No. UDI-DI VKMO 10000-USA 701070441 4058863153841 VKMO 11000-USA 701070445 4058863153889 All lots

Product: QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-USA 701067936 Small Adult with filter, with BIOLINE Coating BEQ-HMO 71100-USA 701067880 Adult with filter, with BIOLINE Coating HMO 50100-USA 701067934 Small Adult without filter, with SOFTLINE Coating HMO 51100-USA 701067938 Small Adult with filter, with SOFTLINE Coating HMO 70100-USA 701067874 Ad

Model Item No. UDI-DI BEQ-HMO 51100-USA 701067936 n/a BEQ-HMO 71100-USA 701067880 4058863164052 HMO 50100-USA 701067934 n/a HMO 51100-USA 701067938 n/a HMO 70100-USA 701067874 n/a HMO 71100-USA 701067886 n/a All lots

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92003

Status: Active

Manufacturer: Maquet Medical Systems USA

Manufactured In: United States

Units Affected: 10 products (8,670 (US); 15,880 (US); 1,784 (US); 0 (US); 0 (US); 0 (US); 0 (US); 0 (US); 0 (US); 0 (US))

Agency Last Updated: June 1, 2023

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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

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