Bio-Stable 5F SL-55CM IR-145 Kit Valved PG, Catalog Number 45-818

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    UPN: H965458180; Lot: 5303175, 5305572
  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:
Angiodynamics Inc. (Navilyst Medical Inc.)
Reason for Recall:
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Bio-Stable 5F SL-55CM IR-145 Kit Valved PG, Catalog Number 45-818

Product Codes/Lot Numbers:

UPN: H965458180; Lot: 5303175, 5305572

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2189-2018

Related Recalls

Mislabeled: The product is labeled as 5F (55cm; Maximum Flow Rate 3.5 mL/Sec) and the product is actually 4F (55cm; Maximum Flow Rate 3.5 mL/Sec).

Oct 17, 2017 Other Medical Devices View Details →

AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantable Infusion Port kits and Valved introducers that may have potential for compromised sterility of the device. Only the specific product/lot of the kit identified below is affected by this recall action. The Product Description, Product Number, Ref./Catalog Number and Batch/Lot number is provided below. No other products are affected by this recall.

Feb 22, 2021 Surgical Instruments Nationwide View Details →

AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantable Infusion Port kits and Valved introducers that may have potential for compromised sterility of the device. Only the specific product/lot of the kit identified below is affected by this recall action. The Product Description, Product Number, Ref./Catalog Number and Batch/Lot number is provided below. No other products are affected by this recall.

Feb 22, 2021 Implants & Prosthetics Nationwide View Details →