🔍 RecallPedia

EZ Breathe Atomizer Model # EZ-100. For the delivery of liquid medications for respiratory usage.

Class I - Dangerous
🏥 Medical Devices Recalled: April 30, 2013 Nephron Pharmaceuticals Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    Model # EZ-100 Lots # R2029A, R2029B, R2039A, R2042A, R2045A, and R2047A. Atomizer Serial Number Ranges: 1206034476-1206069065 1207003710-1237038299 1207046505-1207081124 1208027421-1208062155 1209000001-1209069179 1209069180-1209069202 1209069203-1209069460 1210000001-1210103680 1210104001-1210104044
  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:
Nephron Pharmaceuticals Corp.
Reason for Recall:
Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

EZ Breathe Atomizer Model # EZ-100. For the delivery of liquid medications for respiratory usage.

Product Codes/Lot Numbers:

Model # EZ-100 Lots # R2029A, R2029B, R2039A, R2042A, R2045A, and R2047A. Atomizer Serial Number Ranges: 1206034476-1206069065 1207003710-1237038299 1207046505-1207081124 1208027421-1208062155 1209000001-1209069179 1209069180-1209069202 1209069203-1209069460 1210000001-1210103680 1210104001-1210104044

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1371-2013

Related Recalls

Sodium Chloride Inhalation Solution, USP 3%, 60 x 4 mL Sterile Unit-Dose Vials per carton, Rx Only, NDC 0487-9003-60. A vial contains sterile, preservation-free, clear, colorless, aqueous solution as labeled for induction of sputum production where specimen collection is indicated. For respiratory therapy, Solium Chloride Inhalation Solution USP, 3% is used in conjunction with a nebulizer

Nephron Pharmaceuticals

Class I - Dangerous

Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the vial.

Nov 16, 2015 Other Medical Devices Nationwide View Details →

Sodium Chloride Inhalation Solution, USP 7%, 60 x 4 mL Sterile Unit-Dose Vials, Rx Only, NDC 0487-9007-60. A vial contains sterile, preservation-free, clear, colorless, aqueous solution as labeled for induction of sputum production where specimen collection is indicated. For respiratory therapy, Solium Chloride Inhalation Solution USP, 3% is used in conjunction with a nebulizer

Nephron Pharmaceuticals

Class I - Dangerous

Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the vial.

Nov 16, 2015 Other Medical Devices Nationwide View Details →