Device recall: 6" Trifurcated Extension Set, Product Code: AMS-375-1 Accessory device used to administer medical fluids
Class II FDA enforcement event 70369. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Potential for leaking caused by insufficient bond between needleless device and female luer.
Class II, in the words of FDA
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
Churchill Medical Systems, Inc. started this device recall on 15 Jan 2015. The firm address in the FDA record is in Dover, NH. FDA put the recall in Class II. FDA event 70369 has 12 product records. The first FDA enforcement report date is 29 Apr 2015. The record gives the status Terminated, with the termination date 25 Feb 2016.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide Distribution including TX, OH, NY, CA, UT, PA, MA, NY, VA, and IL.
Recalling firm
Churchill Medical Systems, Inc., Dover, NH.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
12 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1467-2015 | 6" Trifurcated Extension Set, Product Code: AMS-375-1 Accessory device used to administer medical fluids | 5,200 | Class II | Terminated | 29 Apr 2015 |
| Z-1468-2015 | Bifircated Extension Set, Product Code: BN-828 Accessory device used to administer medical fluids | 100 | Class II | Terminated | 29 Apr 2015 |
| Z-1469-2015 | 4" Microbore Double Lumen Set with Bionector, Product Code: BN-208 Accessory device used to administer medical fluids | 2350 | Class II | Terminated | 29 Apr 2015 |
| Z-1470-2015 | 4" Microbore Trifurcated Ext set, Product Code: BN-308 Accessory device used to administer medical fluids | 2200 | Class II | Terminated | 29 Apr 2015 |
| Z-1471-2015 | 4" Microbore T-Port Set, Product Code: BN-448 Accessory device used to administer medical fluids | 450 | Class II | Terminated | 29 Apr 2015 |
| Z-1472-2015 | 8" Standard Bore Ext Set, Product Code: BN-481 Accessory device used to administer medical fluids | 0 | Class II | Terminated | 29 Apr 2015 |
| Z-1473-2015 | 7" High Pressure Set with Bionector, Product Code: CMS-808 and CMS-808-1 Accessory device used to administer medical fluids | 129,500 | Class II | Terminated | 29 Apr 2015 |
| Z-1474-2015 | 7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device used to administer medical fluids | 6850 | Class II | Terminated | 29 Apr 2015 |
| Z-1475-2015 | 7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device used to administer medical fluids | 6850 | Class II | Terminated | 29 Apr 2015 |
| Z-1476-2015 | Bifurcated set with check vales and Bionectors, Product Code: BN-2082CV Accessory device used to administer medical fluids | 1050 | Class II | Terminated | 29 Apr 2015 |
| Z-1477-2015 | 4" Trifurcated set with Bionectors and check valves, Product Code: BN-3082CV and BN-3083CV Accessory device used to administer medical fluids | 2650 | Class II | Terminated | 29 Apr 2015 |
| Z-1478-2015 | 6" Trifurcated set with Bionectors, Product Code: BN-944 Accessory device used to administer medical fluids | 1650 | Class II | Terminated | 29 Apr 2015 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2015
- 1,153
- Share of these events in Class II
- 91%
- Product records in this event
- 12Median of the firm: 2
- Events of the firm on the register
- 4
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 7 Jan 2014 | AMS-530 7” Microbore Trifurcated Extension sets Product Usage: Intravascular administration set. | Device | Class II | 1 |
| 12 Aug 2013 | Vygon 14 Microbore Extension Set with Bionector, CMS-814-1. The CMS-814-1 is a 14 inch extension set used to administer | Device | Class II | 2 |
| 21 Jan 2013 | Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set used for the infusion of medical fluids | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-1467-2015The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 70369. https://recallregister.com/fda/ii/70369/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide Distribution including TX, OH, NY, CA, UT, PA, MA, NY, VA, and IL.
- What quantity of product is in FDA event 70369?
- The event has 12 product records. The first record gives this quantity:
5,200
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2015 have the same class?
- 91% of the 1,153 device events that started in 2015 are in Class II.