Carefusion 211 Inc dba Carefusion
Complete recall history across all FDA and CPSC categories — 14 total recalls
Carefusion 211 Inc dba Carefusion appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (14)
FDA medical device enforcement actions by Carefusion 211 Inc dba Carefusion
| Date | Product | Reason | Class |
|---|---|---|---|
| May 17, 2016 | AVEA Comprehensive ventilator-refurbished, R17310-xx (xx = 0-14) A continuo... | CareFusion has identified a potential risk associated with AVEA Ventilator ca... | Class I |
| May 17, 2016 | AVEA Comprehensive ventilator, 17310-xx (xx = 0 - 14) A continuous ventila... | CareFusion has identified a potential risk associated with AVEA Ventilator ca... | Class I |
| May 17, 2016 | AVEA Standard ventilator-refurbished, R17311-xx (xx = 0-14) A continuous ven... | CareFusion has identified a potential risk associated with AVEA Ventilator ca... | Class I |
| May 17, 2016 | AVEA GDE upgrade kit, 12284-PMN A continuous ventilator intended to mechanic... | CareFusion has identified a potential risk associated with AVEA Ventilator ca... | Class I |
| May 17, 2016 | AVEA Standard with Compressor ventilator, 17312-xx (xx = 0 - 14) A continuo... | CareFusion has identified a potential risk associated with AVEA Ventilator ca... | Class I |
| May 17, 2016 | Gas Delivery Engine (GDE)-1st Generation, 16222-001-99 A continuous ventilat... | CareFusion has identified a potential risk associated with AVEA Ventilator ca... | Class I |
| May 17, 2016 | AVEA GDE/UIM upgrade kit, 12283-PMN A continuous ventilator intended to mech... | CareFusion has identified a potential risk associated with AVEA Ventilator ca... | Class I |
| May 17, 2016 | AVEA Standard ventilator, 17311-xx (xx = 0 - 14) A continuous ventilator in... | CareFusion has identified a potential risk associated with AVEA Ventilator ca... | Class I |
| May 17, 2016 | AVEA Standard with Compressor ventilator-refurbished, R17312-xx (xx = 0-14) ... | CareFusion has identified a potential risk associated with AVEA Ventilator ca... | Class I |
| May 17, 2016 | TCA Board, 16542A A continuous ventilator intended to mechanically control o... | CareFusion has identified a potential risk associated with AVEA Ventilator ca... | Class I |
| May 17, 2016 | Gas Delivery Engine (GDE)-refurbished, R16650A A continuous ventilator inten... | CareFusion has identified a potential risk associated with AVEA Ventilator ca... | Class I |
| May 17, 2016 | Gas Delivery Engine (GDE), 16650A A continuous ventilator intended to mechan... | CareFusion has identified a potential risk associated with AVEA Ventilator ca... | Class I |
| Apr 3, 2015 | CareFusion AVEA ventilator, all models. Product Usage: A continuous venti... | A pressure transducer failure can develop, activating a false Extended High P... | Class I |
| Sep 5, 2013 | Product Name: AVEA¿ Ventilator. All Models. The affected devices are clear... | CareFusion has identified a potential risk associated with AVEA¿ ventilators ... | Class I |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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