Covidien: Medical Device Recall in 2024 - (Recall #: Z-1330-2024)
See the recall detail below. You can also see other recalls from the same firm in 2024.
Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1
Class II
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.
UDI-DI: 20884521700953, 10884521700956. Lots: 230504KF, 220903KF, 221102KF
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.
Voluntary: Firm initiated
