QUADROX-iD Pediatric, Oxygenator used during… recallZ-1658-2023 · Maquet Medical Systems USA · initiated May 18, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Maquet Medical Systems USA or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.
FDA root cause category: Under Investigation by firm
What the company is doing
On May 18, 2023, the firm notified customers of the recall via an Urgent Medical Device Removal letter. Actions to be taken by the customer: If an affected device is already in use, please use according to normal practices. Monitor the patient for signs and symptoms of inflammation, infection, sepsis, and ischemia. If detected, treat according to clinical protocols. Please remove any affected product in inventory from areas of use. Unopened and unexpired affected product is eligible for credit upon return. Product Return: Please contact Getinge Customer Service at 1-888-943-8872 option 2 between the hours of 6:00 AM and 5:00 PM Pacific Standard Time to request a return authorization (RMA) and shipping instructions to return any affected product. Distributors who have shipped affected products to customers should forward the notification to customers' attention for appropriate action. Maquet Cardiopulmonary GmbH is working with all possible urgency on the redesign and revalidation of a packaging solution, which is anticipated to be available by Q4 2023.
Recall details
- Recall number
- Z-1658-2023
- Status
- Open, Classified
- Initiated by the company
- May 18, 2023
- Posted by the FDA
- May 30, 2023
- Recalling firm
- Maquet Medical Systems USA
- Quantity
- 5,022 (US)
- Product code
- DTZ
- FDA submissions
- K100278
- Distribution
- Nationwide domestic distribution
Product description
QUADROX-iD Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. BEQ-HMOD30000-USA 701070397 BEQ-HMOD30000-USA 701050330
Code information (models, lots, serial numbers)
Model Item No. UDI-DI BEQ-HMOD30000-USA 701070397 4058863154435 BEQ-HMOD30000-USA 701050330 4037691670164 All lots
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- QUADROX-i Pediatric, diffusion, BIOLINEMaquet Cardiopulmonary AG · HEAT-EXCHANGER, CARDIOPULMONARY BYPASS2 recalls0 reports
- Quadrox-iD BEQ-HMOD30000-USAMaquet Cardiopulmonary AG · Heat-Exchanger, Cardiopulmonary Bypass1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 92006).
- Z-1656-2023 · Open, ClassifiedQUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMOD 70000-USA 701067840 BEQ-HMOD70000-USA 701067859
- Z-1657-2023 · Open, ClassifiedQUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. BEQ-HMO 50000-USA 701067905 HMO 50000-USA 7010678…
- Z-1659-2023 · Open, ClassifiedQUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 70000-USA 701067820 HMO 71000-USA …
- Z-1662-2023 · Open, ClassifiedQUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-USA 701067936 Small Adult wi…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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