QUADROX-iD Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. BEQ-HMOD30000-USA 701070397 BEQ-HMOD30000-USA 701050330
Reported: June 7, 2023 Initiated: May 18, 2023 #Z-1658-2023
Product Description
QUADROX-iD Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. BEQ-HMOD30000-USA 701070397 BEQ-HMOD30000-USA 701050330
Reason for Recall
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.
Details
- Recalling Firm
- Maquet Medical Systems USA
- Units Affected
- 5,022 (US)
- Distribution
- Nationwide domestic distribution
- Location
- Wayne, NJ
Frequently Asked Questions
What product was recalled? ▼
QUADROX-iD Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. BEQ-HMOD30000-USA 701070397 BEQ-HMOD30000-USA 701050330. Recalled by Maquet Medical Systems USA. Units affected: 5,022 (US).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 7, 2023. Severity: Moderate. Recall number: Z-1658-2023.
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