The Recall Desk

Manufacturer

Churchill Medical Systems, Inc.

16 recalls in our database name Churchill Medical Systems, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
16
Critical
0
Severe
0
Most recent
2015-04-29

Of the 16 recalls from Churchill Medical Systems, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–16 of 16

  • HighFDA (Devices)·Z-1467-2015·2015-04-29

    Churchill Medical Systems Recalls 6-Inch Trifurcated Extension Sets for Leaking Risk

    Churchill Medical Systems is recalling 5,200 6-inch trifurcated extension sets due to a potential leak caused by insufficient bonding between the needleless device and female luer.

    Product
    6" Trifurcated Extension Set, Product Code: AMS-375-1 Accessory device used to administer medical fluids
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1470-2015·2015-04-29

    Churchill Medical Systems Recalls 4-inch Microbore Trifurcated Extension Sets

    Churchill Medical Systems is recalling 2,200 units of 4-inch Microbore Trifurcated Extension Sets due to a potential leak caused by insufficient bonding between the needleless device and female luer.

    Product
    4" Microbore Trifurcated Ext set, Product Code: BN-308 Accessory device used to administer medical fluids
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1471-2015·2015-04-29

    Churchill Medical 4-inch Microbore T-Port Set Recalled for Leaking Risk

    Churchill Medical Systems is recalling 450 units of 4-inch Microbore T-Port Sets due to a potential leak caused by insufficient bonding between components.

    Product
    4" Microbore T-Port Set, Product Code: BN-448 Accessory device used to administer medical fluids
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1469-2015·2015-04-29

    Churchill Medical Systems Recalls 4-inch Microbore Double Lumen Sets

    Churchill Medical Systems is recalling 2,350 units of 4-inch Microbore Double Lumen Sets due to a potential leak caused by an insufficient bond between the needleless device and the female luer.

    Product
    4" Microbore Double Lumen Set with Bionector, Product Code: BN-208 Accessory device used to administer medical fluids
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1472-2015·2015-04-29

    Churchill Medical Systems Recalls 8 Inch Standard Bore Extension Sets

    Churchill Medical Systems is recalling 8-inch Standard Bore Extension Sets due to a potential leak caused by insufficient bonding between the needleless device and the female luer.

    Product
    8" Standard Bore Ext Set, Product Code: BN-481 Accessory device used to administer medical fluids
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1476-2015·2015-04-29

    Churchill Medical Systems Recalls Bifurcated Sets Due to Leaking Risk

    Churchill Medical Systems is recalling 1,050 bifurcated sets with check valves and Bionectors due to a potential for leaking caused by insufficient bonding.

    Product
    Bifurcated set with check vales and Bionectors, Product Code: BN-2082CV Accessory device used to administer medical fluids
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1474-2015·2015-04-29

    Churchill Medical Systems Recalls 7-Inch High Pressure Extension Sets

    Churchill Medical Systems is recalling 6,850 units of 7-inch Standard Bore High Pressure Extension Sets due to a potential leak caused by insufficient bonding between the needleless device and female luer.

    Product
    7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device used to administer medical fluids
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1475-2015·2015-04-29

    Churchill Medical Systems Recalls 7-inch High Pressure Extension Sets

    Churchill Medical Systems is recalling 6,850 units of 7-inch Standard Bore High Pressure Extension Sets due to a potential leak caused by insufficient bonding.

    Product
    7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device used to administer medical fluids
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1477-2015·2015-04-29

    Churchill Medical Systems Recalls 4-inch Trifurcated Sets Due to Leaking Risk

    Churchill Medical Systems is recalling 2,650 units of 4-inch trifurcated sets with Bionectors and check valves due to a potential for leaking caused by insufficient bonding.

    Product
    4" Trifurcated set with Bionectors and check valves, Product Code: BN-3082CV and BN-3083CV Accessory device used to administer medical fluids
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1468-2015·2015-04-29

    Churchill Medical Systems Recalls Bifurcated Extension Sets Due to Leaking Risk

    Churchill Medical Systems is recalling 100 Bifurcated Extension Sets because a defect may cause leaking. The sets are used to administer medical fluids.

    Product
    Bifircated Extension Set, Product Code: BN-828 Accessory device used to administer medical fluids
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1478-2015·2015-04-29

    Churchill Medical Systems Recalls 6-inch Trifurcated Sets with Bionectors

    Churchill Medical Systems is recalling 1,650 6-inch trifurcated sets with Bionectors due to a potential leak caused by insufficient bonding between the needleless device and the female luer.

    Product
    6" Trifurcated set with Bionectors, Product Code: BN-944 Accessory device used to administer medical fluids
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1473-2015·2015-04-29

    Churchill Medical Systems Recalls 7-Inch High Pressure Sets Due to Leaking Risk

    Churchill Medical Systems is recalling 129,500 units of 7-inch High Pressure Sets with Bionector due to a potential for leaking caused by insufficient bonding.

    Product
    7" High Pressure Set with Bionector, Product Code: CMS-808 and CMS-808-1 Accessory device used to administer medical fluids
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0813-2014·2014-01-29

    Churchill Medical AMS-530 Microbore Extension Sets Recalled for Leaking

    Churchill Medical Systems is recalling AMS-530 Microbore Trifurcated Extension sets because a defective component may cause the sets to leak.

    Product
    AMS-530 7 Microbore Trifurcated Extension sets Product Usage: Intravascular administration set.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2251-2013·2013-09-25

    Churchill Medical Recalls Vygon 14 Microbore Extension Sets

    Churchill Medical Systems is recalling 13,100 Vygon 14 Microbore Extension Sets because the tubing may disconnect from the male luers.

    Product
    Vygon 14 Microbore Extension Set with Bionector, CMS-814-1. The CMS-814-1 is a 14 inch extension set used to administer IV fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2252-2013·2013-09-25

    Churchill Medical Systems Recalls Central Dressing Change Kits

    Churchill Medical Systems is recalling 3,040 Central Dressing Change Kits because microbore tubing may disconnect from male luers on the extension sets.

    Product
    Central Dressing Change Kit; AMS-8464CP- 6. Vygon Central Dressing Change Kit contains: 1 Pair Nitrile Gloves W/Wallet, Powderfree 1 Face Mask 1 Polylined Drape, 13" X 18" 1 ChloraPrep***, 3ml Applicator W/Insert 1 Pkg. Alcohol Swabsticks (3/Pkg.) 1 14" Extension Set W/Bionecto
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0914-2013·2013-03-13

    Churchill Medical Recalls Lifeguard Infusion Sets Due to Labeling Error

    Churchill Medical Systems is recalling 2,340 Lifeguard Infusion Sets because the labels incorrectly identify the needle gauge and item number.

    Product
    Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set used for the infusion of medical fluids into implantable ports.
    Category
    Medical Device
    Distribution
    Distributed nationwide