Medical Device Recall: Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1
Covidien · February 21, 2024
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.
Distribution
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.
States Affected
NATIONWIDE
Quantity Affected
755,800
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1330-2024
Status: ongoing
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