Situate Laparotomy Sponge recall: Sterility Concern
Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1
Why was Situate Laparotomy Sponge 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 20884521700953, 10884521700956. Lots: 230504KF, 220903KF, 221102KF
- Product
- Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1
- Recalling firm
- Covidien
- Quantity
- 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.
- Recall date
- March 27, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)