Z-1330-2024 Class II Ongoing
FDA device recall Z-1330-2024 was initiated by Covidien on Feb 21, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 755,800.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 27, 2024
- Initiation Date
- Feb 21, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 755,800
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.
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.
Code Information
UDI-DI: 20884521700953, 10884521700956. Lots: 230504KF, 220903KF, 221102KF
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1330-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026