AMS-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651 Product Usage: Accessory devices used to administer medical fluids.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 1601064D 1603065D 1605009D 1606038D 1607016D 1607072D 1608067D 1609069D
- 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 is 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-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651 Product Usage: Accessory devices used to administer medical fluids.
Product Codes/Lot Numbers:
1601064D 1603065D 1605009D 1606038D 1607016D 1607072D 1608067D 1609069D
Distribution:
Distributed in: US, CA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0787-2017
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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.