FDA recall Z-1330-2024

Covidien · Class II · device

Product

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

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.

Key facts

Status
Ongoing
Initiation date
2024-02-21
Report date
2024-03-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lafayette, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1330-2024