FDA-Device2024-03-27Class II
Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1
Covidien
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.
Sold states
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.
Affected count
755,800
Manufactured in
200 Medtronic Dr, Lafayette, CO, United States
Products
Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1330-2024Don't want to check this manually?
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