Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood products to a human patient.
Class I - DangerousWhat Should You Do?
- Check if you have this product: LOT # 20080416-zs5, 20080711-zs5, 20080826-zs5, 20081022-zs5, 20090126-zs5 20090320-zs5, 20090507-zs5, 20090612-zs5, 20090706-zs5,20090910-zs5 20091110-zs5, 20100106-C, 20100420-D, 20100729, 20101005-BJ 20100910-SH, 20101013-SH, 20101206-SH, 20110110-SH, 20110111-SH 20110204-SH, 20110210-SH, 20110308-SH, 20110505-SH
- 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:
- Zyno Medical LLC
- Reason for Recall:
- Update Instruction For Use for Preventative Maintenance (PM) Schedule and addition of Odometer software to monitor accumulative fluid volume infused by the pump
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood products to a human patient.
Product Codes/Lot Numbers:
LOT # 20080416-zs5, 20080711-zs5, 20080826-zs5, 20081022-zs5, 20090126-zs5 20090320-zs5, 20090507-zs5, 20090612-zs5, 20090706-zs5,20090910-zs5 20091110-zs5, 20100106-C, 20100420-D, 20100729, 20101005-BJ 20100910-SH, 20101013-SH, 20101206-SH, 20110110-SH, 20110111-SH 20110204-SH, 20110210-SH, 20110308-SH, 20110505-SH
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1024-2013
Related Recalls
Unreleased software versions were installed on distributed devices without verification or validation.
Unreleased software versions were installed on distributed devices without verification or validation.
Unreleased software versions were installed on distributed devices without verification or validation.