Recall Z-1330-2024— Covidien
Class II · Ongoing
Class II FDA medical device recall by Covidien, initiated 2024-02-21. FDA's recall record names no specific 510(k) clearance for this event. Product: Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1. 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..
- Recalling firm
- Covidien
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-02-21
- Firm location
- Lafayette, CO, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.