The Recall Desk

Manufacturer

Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.

9 recalls in our database name Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
9
Critical
0
Severe
0
Most recent
2019-12-04

Of the 9 recalls from Vygon MFG, Inc., dba/ 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.

1–9 of 9

  • ModerateFDA (Devices)·Z-0585-2020·2019-12-04

    Vygon Recalls 4Fr CT Midline Catheter Trays Due to Sizing Error

    Vygon MFG, Inc. is recalling 75 units of 4Fr x 20cm Single Lumen CT Midline Basic Trays because a 3Fr catheter may have been packaged instead of the correct 4Fr size.

    Product
    4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0933-2018·2018-03-21

    Vygon IV Start Convenience Kits Recalled for Iodine Stability Issues

    Vygon MFG, Inc. is recalling IV Start Convenience Kits because the iodine prep pads failed stability testing for their expiration date.

    Product
    Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when administering IV during emergency.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0682-2018·2018-02-28

    Vygon Recalls 3-Way Stopcocks Due to Packaging Sterility Concerns

    Vygon is voluntarily recalling 200 units of 3-Way Standardbore Stopcocks because packaging adhesive issues may compromise product sterility.

    Product
    3-Way Standardbore Stopcock. Product Code: AMS-100.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0678-2018·2018-02-28

    Voluntary Recall of Nutrisafe 2 Syringes Due to Packaging Adhesive Issues

    Vygon is voluntarily recalling specific lots of Nutrisafe 2 syringes because packaging adhesive gaps may compromise sterility.

    Product
    Nutrisafe 2 35 mL Syringe for Safety Connection. Product Code: 1015.352M
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0680-2018·2018-02-28

    Vygon Recalls Pediatric CVC Trays Due to Packaging Adhesive Defect

    Vygon is voluntarily recalling 300 units of CVC Tray Pediatrics because packaging adhesive gaps may compromise sterility.

    Product
    CVC Tray Pediatrics. Product Code: AMS-9335CP-2.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0679-2018·2018-02-28

    Vygon Recalls LifeGuard Huber Needles Due to Packaging Sterility Concerns

    Vygon is voluntarily recalling 396 units of LifeGuard Huber Needles because packaging adhesive gaps may compromise sterility.

    Product
    20Ga x .75 LifeGuard Huber Needle with Y-site. Product Code: CLGY-2034.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1484-2017·2017-03-29

    FDA Recalls Microbore Extension Sets Due to Incorrect Priming Volume Labeling

    Vygon MFG is recalling 30,700 AMS-636 Microbore extension sets because the package displays an incorrect priming volume.

    Product
    AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to administer medical fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0787-2017·2016-12-28

    FDA Recalls Microbore Extension Sets Due to Incorrect Priming Volume Labeling

    Vygon MFG, Inc. is recalling 31,500 AMS-651 Microbore extension sets because the package displays an incorrect priming volume.

    Product
    AMS-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651 Product Usage: Accessory devices used to administer medical fluids.
    Category
    Medical Device
    Distribution
    1 state