Churchill Medical Systems, Inc.
Complete recall history across all FDA and CPSC categories — 16 total recalls
Churchill Medical Systems, Inc. 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 (16)
FDA medical device enforcement actions by Churchill Medical Systems, Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Jan 15, 2015 | Bifircated Extension Set, Product Code: BN-828 Accessory device used to admi... | Potential for leaking caused by insufficient bond between needleless device a... | Class II |
| Jan 15, 2015 | 7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory devi... | Potential for leaking caused by insufficient bond between needleless device a... | Class II |
| Jan 15, 2015 | Bifurcated set with check vales and Bionectors, Product Code: BN-2082CV Acce... | Potential for leaking caused by insufficient bond between needleless device a... | Class II |
| Jan 15, 2015 | 8" Standard Bore Ext Set, Product Code: BN-481 Accessory device used to admi... | Potential for leaking caused by insufficient bond between needleless device a... | Class II |
| Jan 15, 2015 | 7" High Pressure Set with Bionector, Product Code: CMS-808 and CMS-808-1 Acc... | Potential for leaking caused by insufficient bond between needleless device a... | Class II |
| Jan 15, 2015 | 6" Trifurcated Extension Set, Product Code: AMS-375-1 Accessory device used ... | Potential for leaking caused by insufficient bond between needleless device a... | Class II |
| Jan 15, 2015 | 4" Microbore Double Lumen Set with Bionector, Product Code: BN-208 Accessory... | Potential for leaking caused by insufficient bond between needleless device a... | Class II |
| Jan 15, 2015 | 7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory devi... | Potential for leaking caused by insufficient bond between needleless device a... | Class II |
| Jan 15, 2015 | 6" Trifurcated set with Bionectors, Product Code: BN-944 Accessory device us... | Potential for leaking caused by insufficient bond between needleless device a... | Class II |
| Jan 15, 2015 | 4" Microbore Trifurcated Ext set, Product Code: BN-308 Accessory device used... | Potential for leaking caused by insufficient bond between needleless device a... | Class II |
| Jan 15, 2015 | 4" Microbore T-Port Set, Product Code: BN-448 Accessory device used to admin... | Potential for leaking caused by insufficient bond between needleless device a... | Class II |
| Jan 15, 2015 | 4" Trifurcated set with Bionectors and check valves, Product Code: BN-3082CV ... | Potential for leaking caused by insufficient bond between needleless device a... | Class II |
| Jan 7, 2014 | AMS-530 7 Microbore Trifurcated Extension sets Product Usage: Intravas... | Defective component may cause extension sets to leak. | Class II |
| Aug 12, 2013 | Central Dressing Change Kit; AMS-8464CP- 6. Vygon Central Dressing Change K... | Microbore tubing disconnecting from male luers on the extension sets. | Class II |
| Aug 12, 2013 | Vygon 14 Microbore Extension Set with Bionector, CMS-814-1. The CMS-814-1 is ... | Microbore tubing disconnecting from male luers on the extension sets. | Class II |
| Jan 21, 2013 | Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needl... | The label on the device states that the item number is CLGY-2210 when the ite... | Class II |
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.
Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.
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