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Vygon MFG, Inc., dba/ Churchill Medical Systems Recalls
9 recalls on record · December 28, 2016 to December 4, 2019 · Medical Devices
Recalls by year
16
17
18
19
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
December 4, 2019Medical DevicesFDA
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. recalls 4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001
Hazard: Potential that 3Fr size catheter placed in the catheter tray instead of 4Fr for the 4Fr x 20cm Single Lumen CT Midline Basic Tray.
March 21, 2018Medical DevicesFDA
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. recalls Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when administering IV during emer
Hazard: The Iodine Prep Pads within the Vygon IV Start Convenience Kits, had stability samples that were not meeting iodine assay level requirements to support the 36 month expiration date. All kits containing the affected pads were recalled.
February 28, 2018Medical DevicesFDA
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. recalls 3-Way Standardbore Stopcock. Product Code: AMS-100.
Hazard: Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyvek supplier has notified Vygon of issues with their product, specifically the Tyvek may not be coated completely causing gaps in the adhesive used to seal the product packaging. This potential lack of adhesive may affect the sterility of the product.
February 28, 2018Medical DevicesFDA
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. recalls 19Ga x 1 Huber Needle Set. Product Code: MBS-1910.
Hazard: Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyvek supplier has notified Vygon of issues with their product, specifically the Tyvek may not be coated completely causing gaps in the adhesive used to seal the product packaging. This potential lack of adhesive may affect the sterility of the product.
February 28, 2018Medical DevicesFDA
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. recalls CVC Tray Pediatrics. Product Code: AMS-9335CP-2.
Hazard: Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyvek supplier has notified Vygon of issues with their product, specifically the Tyvek may not be coated completely causing gaps in the adhesive used to seal the product packaging. This potential lack of adhesive may affect the sterility of the product.
February 28, 2018Medical DevicesFDA
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. recalls 20Ga x .75 LifeGuard Huber Needle with Y-site. Product Code: CLGY-2034.
Hazard: Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyvek supplier has notified Vygon of issues with their product, specifically the Tyvek may not be coated completely causing gaps in the adhesive used to seal the product packaging. This potential lack of adhesive may affect the sterility of the product.
February 28, 2018Medical DevicesFDA
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. recalls Nutrisafe 2 35 mL Syringe for Safety Connection. Product Code: 1015.352M
Hazard: Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyvek supplier has notified Vygon of issues with their product, specifically the Tyvek may not be coated completely causing gaps in the adhesive used to seal the product packaging. This potential lack of adhesive may affect the sterility of the product.
March 29, 2017Medical DevicesFDA
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. recalls AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to administer medical fluids.
Hazard: Incorrect priming volume printed on the device package.
December 28, 2016Medical DevicesFDA
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. recalls AMS-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651 Product Usage: Accessory devices used
Hazard: Incorrect priming volume is printed on the device package.