Maquet Medical Systems USA: Medical Device Recall in 2023 - (Recall #: Z-1641-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: May 18, 2023

Date Posted: June 7, 2023

Recall Number: Z-1641-2023

Event ID: 92003

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 0 (US)

Code Information:

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

Distribution Pattern:

Domestic distribution nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated