QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMOD 70000-USA 701067840 BEQ-HMOD70000-USA 701067859
Reported: June 7, 2023 Initiated: May 18, 2023 #Z-1656-2023
Product Description
QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMOD 70000-USA 701067840 BEQ-HMOD70000-USA 701067859
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
- 24,250 (US)
- Distribution
- Nationwide domestic distribution
- Location
- Wayne, NJ
Frequently Asked Questions
What product was recalled? ▼
QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMOD 70000-USA 701067840 BEQ-HMOD70000-USA 701067859. Recalled by Maquet Medical Systems USA. Units affected: 24,250 (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-1656-2023.
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