Reported Mar 27, 2024 · Ongoing
Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1
Covidien
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Covidien · 200 Medtronic Dr · Lafayette, CO · 80026
Is this the product you have?
- Situate Laparotomy Sponge, RF and X-ray Detectable
- REFL1818-04P01C-1
- Lot codes and dates
- UDI-DI
2088452170095310884521700956
- Lots
230504KF220903KF221102KF
- UDI-DI
- Amount recalled
- 755,800
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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