Catalog No. 1443 DRESSING CHANGE TRAY / STERILE - LATEX FREE

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    UDI-DI 00849233010727 Lots 2210077 2210112 2310275 2310331
  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:
Busse Hospital Disposables, Inc.
Reason for Recall:
Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. Nurse Assist identified product in distribution for which the required sterility assurance level (SAL) of 10^-6 cannot be guaranteed. Risks to patients if product is used include blood stream infections, urinary tract infections, or respiratory infections; in the worst-case scenario, there is risk of sepsis or death.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Catalog No. 1443 DRESSING CHANGE TRAY / STERILE - LATEX FREE

Product Codes/Lot Numbers:

UDI-DI 00849233010727 Lots 2210077 2210112 2310275 2310331

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0593-2024

Related Recalls

Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. Nurse Assist identified product in distribution for which the required sterility assurance level (SAL) of 10^-6 cannot be guaranteed. Risks to patients if product is used include blood stream infections, urinary tract infections, or respiratory infections; in the worst-case scenario, there is risk of sepsis or death.

Nov 30, 2023 Other Medical Devices Nationwide View Details →
Class I - Dangerous

Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. Nurse Assist identified product in distribution for which the required sterility assurance level (SAL) of 10^-6 cannot be guaranteed. Risks to patients if product is used include blood stream infections, urinary tract infections, or respiratory infections; in the worst-case scenario, there is risk of sepsis or death.

Nov 30, 2023 Other Medical Devices Nationwide View Details →