Summary
The FDA issued a Class II for Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1 by Covidien. Reason: Packs including 5 laparotomy sponges may contain incorrect product with a blue loop, X-ray detectable feature, and ethylene oxide treatment; however,.
Details
Source
Device Recall
External ID
Z-1330-2024
Action Date
2024-03-27
Status
Ongoing
Category
device
Product Description
Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1
Lot/Code Info: UDI-DI: 20884521700953, 10884521700956. Lots: 230504KF, 220903KF, 221102KF
Quantity Affected: 755,800
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
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-02-21
Company
Lafayette, CO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 158 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Covidien has 33 FDA actions in our database, including 17 recalls and 16 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Covidien) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Covidien have FDA actions?
Covidien has 33 FDA actions in our database, including 17 recalls and 16 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1330-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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