Food, drugs, devices › Maquet Cardiovascular Us Sales, Llc
Device recall: QUADROX-i oxygenators Custom tubing packs for the oxygenator
FDA enforcement event 73390 is a device recall by Maquet Cardiovascular Us Sales, Llc of Wayne, NJ, initiated 23 Feb 2016 and classified Class II, with 4 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,232 device enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 25 Sep 2019. Initiation: voluntary: firm initiated. Maquet Cardiovascular Us Sales, Llc has 40 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Maquet Cardiovascular Us Sales, Llc, Wayne, NJ.
Reason for recall
"Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products."
Distribution
"US Nationwide Distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1371-2016 | QUADROX-i oxygenators Custom tubing packs for the oxygenator | 72,000 units in total | Class II | Terminated | 20 Apr 2016 |
| Z-1372-2016 | HLS Set Advanced with BIOLINE Coating Custom tubing packs for the oxygenator | 72,000 units in total | Class II | Terminated | 20 Apr 2016 |
| Z-1373-2016 | Rotaflow Centrifugal Pump Custom tubing packs for the oxygenator | 72,000 units in total | Class II | Terminated | 20 Apr 2016 |
| Z-1374-2016 | Custom Tubing Packs Custom tubing pack for oxygenators | 72,000 units in total | Class II | Terminated | 20 Apr 2016 |
Context
Other enforcement events for Maquet Cardiovascular Us Sales, Llc
All 40 events for Maquet Cardiovascular Us Sales, Llc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide Distribution."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 25 Sep 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.