Kendall Spill Kit, 6 Per Case, NonsterileI, BB6016K
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lots: 916197X 916881X 919683X 920354X 924620X 928728X 931205X
- 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:
- Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Kendall Spill Kit, 6 Per Case, NonsterileI, BB6016K
Product Codes/Lot Numbers:
Lots: 916197X 916881X 919683X 920354X 924620X 928728X 931205X
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1082-2021
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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.