Device product
Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1
Z-1330-2024
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
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.