Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1
Reported: March 27, 2024 Initiated: February 21, 2024 #Z-1330-2024
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.
Details
- Recalling Firm
- Covidien
- Units Affected
- 755,800
- 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.
- Location
- Lafayette, CO
Frequently Asked Questions
What product was recalled? ▼
Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1. Recalled by Covidien. Units affected: 755,800.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 27, 2024. Severity: Moderate. Recall number: Z-1330-2024.
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