Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI: 20884521700953, 10884521700956. Lots: 230504KF, 220903KF, 221102KF
- 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:
- Covidien
- Reason for Recall:
- Packs including 5 laparotomy sponges may contain incorrect product with a blue loop, X-ray detectable feature, and ethylene oxide treatment; however, this incorrect product wasn't steam pre-treated prior to sterilization, and has no RF tag, which if non-sterile, may lead to infection, tissue trauma, and sepsis, and if in the scannable area, would lead a "CLEAR" display.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1
Product Codes/Lot Numbers:
UDI-DI: 20884521700953, 10884521700956. Lots: 230504KF, 220903KF, 221102KF
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1330-2024
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