Dover, NH, United States
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. recalls
3 recalls recorded since 2018, most recently on 24 September 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)0
Terminated or completed3
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 24 September 2019
- Terminated
- 21 October 2020
- Reason
- Potential that 3Fr size catheter placed in the catheter tray instead of 4Fr for the 4Fr x 20cm Single Lumen CT Midline Basic Tray.
- Distribution
- One Customer Located in TN
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0585-2020
- 4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001
Terminated Class II Medical devices
- Recall started
- 3 October 2017
- Terminated
- 6 January 2020
- Reason
- 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.
- Distribution
- US Distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0933-2018
- Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when administering IV during emergency.
Terminated Class II Medical devices
- Recall started
- 24 July 2017
- Terminated
- 7 November 2019
- Reason
- 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.
- Distribution
- U.S.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0682-2018, Z-0681-2018, Z-0680-2018, Z-0678-2018, Z-0679-2018
- 3-Way Standardbore Stopcock. Product Code: AMS-100.
- 19Ga x 1 Huber Needle Set. Product Code: MBS-1910.
- CVC Tray Pediatrics. Product Code: AMS-9335CP-2.
- Nutrisafe 2 35 mL Syringe for Safety Connection. Product Code: 1015.352M
- 20Ga x .75 LifeGuard Huber Needle with Y-site. Product Code: CLGY-2034.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.