Home › CHALICE MEDICAL LIMITED › Adult Tubing Pack with Paragon Adult Maxi PMP Oxygenator
Adult Tubing Pack with Paragon Adult Maxi PMP Oxygenator
CHALICE MEDICAL LIMITED · Model CME40004 · UDI-DI 05060491614129
1
510(k) clearances
10,703
Adverse events (453 deaths)
107
Recalls
34
Facilities
Description
The Adult Tubing Pack with Paragon Adult Maxi PMP Oxygenator is intended for use in extracorporeal circulation during cardiopulmonary bypass procedures, lasting 6 hours or less.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-12 | Medtronic Perfusion Systems | Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements. |
| 2024-01-16 | Maquet Medical Systems USA | The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis |
| 2024-01-16 | Maquet Medical Systems USA | The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis |
| 2023-05-18 | Maquet Medical Systems USA | 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 resu |
| 2023-05-18 | Maquet Medical Systems USA | 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 c |
| 2023-05-18 | Maquet Medical Systems USA | 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 c |
| 2023-05-18 | Maquet Medical Systems USA | 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 resu |
| 2023-05-18 | Maquet Medical Systems USA | 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 resu |
| 2023-05-18 | Maquet Medical Systems USA | 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 resu |
| 2023-05-18 | Maquet Medical Systems USA | 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 resu |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.