HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI: 00850030354068; Lot Number: 11469666
- 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:
- Access Vascular, Inc
- Reason for Recall:
- Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the Instructions For Use (IFU) which do not include the following warnings statement: HydroPICC Dual Lumen Catheter is for adult use only. There is a potential risk to health should the HydroPICC Dual Lumen Catheter be used in an inadequately sized vessel. There have been no reported adverse events to date.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004
Product Codes/Lot Numbers:
UDI-DI: 00850030354068; Lot Number: 11469666
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0115-2024
Related Recalls
Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the Instructions For Use (IFU) which do not include the following warnings statement: HydroPICC Dual Lumen Catheter is for adult use only. There is a potential risk to health should the HydroPICC Dual Lumen Catheter be used in an inadequately sized vessel. There have been no reported adverse events to date.
The catheter packaged with specific lots of the HydroPICC Kits and HydroMID Kits have a shorter expiration date than what is listed on the outer kit package.
Product Mislabeled on the outer bag and inner kit Tyvek header bag