FDAFDA · Food and drugs·Recall number Z-1330-2024
Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1
Published March 27, 2024 · Recall initiated: February 21, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Covidien
- Distributor
- US Nationwide distribution including in the states of AK, AL, AZ, CA, CO, FL, GA, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, PA, RI, TN, TX, UT, VA, WA, WI, WV.
- Lot
- UDI-DI: 20884521700953, 10884521700956. Lots: 230504KF, 220903KF, 221102KF
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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