FDA Device recall Z-1662-2023
QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-USA 701067936 Small Adult with filter, with BIOLINE…
- FDA Device
- Class II
- ongoing
- Published 2023-06-07
On 2023-06-07 the FDA classified a Class II recall of QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-USA 701067936 Small Adult with filter, with BIOLINE… by Maquet Medical Systems Usa, citing 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 res….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1662-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-05-18 |
| Published | 2023-06-07 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Maquet Medical Systems Usa |
| Distribution | US |
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 Adult without filter, with SOFTLINE Coating HMO 71100-USA 701067886 Adult with filter, with SOFTLINE Coating
Reason
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.
Identifiers
| code_info | Model Item No. UDI-DI BEQ-HMO 51100-USA 701067936 N/A BE…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1662-2023%22
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