SmartSite Syringe Administration Set-Product Package Size 50, Catalog Number: 10798696

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot Number: 18046218 Exp. Date: 04/18/2021 UDI: 50885403234352
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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:
Becton Dickinson & Company
Reason for Recall:
Leaking of the Smartsite Syringe Administration Set. May result in delay or interruption of infusion, under-infusion, contamination of the fluid path and HCP exposure to infusates.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

SmartSite Syringe Administration Set-Product Package Size 50, Catalog Number: 10798696

Product Codes/Lot Numbers:

Lot Number: 18046218 Exp. Date: 04/18/2021 UDI: 50885403234352

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1210-2019

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This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.

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