Covidien, LLC: Device Recall
Recall #Z-2038-2024 · 04/25/2024
Class II: Risk
Recall Details
- Recall Number
- Z-2038-2024
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Covidien, LLC
- Status
- Ongoing
- Date Initiated
- 04/25/2024
- Location
- Santa Clara, CA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Reason for Recall
Due to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements that may lead to various harms.
Product Description
EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only
Distribution Pattern
Worldwide - US Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, DC, FL, GA, IA, IL, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and the countries of Argentina, Australia, Austria, Bahrain, Belgium, Canada, Denmark, Germany, Ireland, Italy, Kuwait, New Zealand, Norway, Portugal, Qatar, South Africa, Switzerland, United Arab Emirates.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.