AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to administer medical fluids.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 1610092D 1611091D 1612068D 1612074D
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
- Reason for Recall:
- Incorrect priming volume printed on the device package.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to administer medical fluids.
Product Codes/Lot Numbers:
1610092D 1611091D 1612068D 1612074D
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1484-2017
Related Recalls
4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001
Vygon MFG, Inc., dba/ Churchill Medical Systems
Potential that 3Fr size catheter placed in the catheter tray instead of 4Fr for the 4Fr x 20cm Single Lumen CT Midline Basic Tray.
Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when administering IV during emergency.
Vygon MFG, Inc., dba/ Churchill Medical Systems
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.
3-Way Standardbore Stopcock. Product Code: AMS-100.
Vygon MFG, Inc., dba/ Churchill Medical Systems
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.