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Recall Observatory FDA recall evidence

Device product

Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1

Z-1330-2024

February 21, 2024

Class II

Product summary

Firm
Covidien
Event
Event 94127
Status
Ongoing
Classification
Class II
Quantity
755,800
Official record key
device-enforcement:Z-1330-2024

Official wording

Reason: 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.

Code information: UDI-DI: 20884521700953, 10884521700956. Lots: 230504KF, 220903KF, 221102KF

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.