Monoject Hypodermic Safety Needle 25G x 5/8" Item Code 1182558 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampules and parts of the body below the surface of the skin.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot No. 15063004, Item Code 1182558, Expires 5/31/2020
- 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:
- Cardinal Health 200, LLC
- Reason for Recall:
- Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR" ; the product did not undergo sterilization process and is non-sterile. The usage of a needle that is not sterile could result in infection. Firm is not aware of any reports of patient harm.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Monoject Hypodermic Safety Needle 25G x 5/8" Item Code 1182558 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampules and parts of the body below the surface of the skin.
Product Codes/Lot Numbers:
Lot No. 15063004, Item Code 1182558, Expires 5/31/2020
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1455-2020
Related Recalls
Webcol Alcohol Prep pad (70% isopropyl alcohol) 2 ply, 200 count boxes, Cardinal Health 200 LLC 3651 Birchwood Drive, Waukegan, IL 60085.
Cardinal Health 200
Non-Sterility: microbial contamination identified as Paenibacillus phoenicis
The firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older. When used on infants, the CDU may not demonstrate tidaling/bubbling, which may confound the clinician's assessment of device functionality and lead to inadequate/inappropriate treatment/therapy, delay to treatment/therapy, and prolonged hospitalization.
Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-life of three years which is mislabeled on the product packaging as five (5) years.