Recall record at a glance
| Official record | Z-0147-2023 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Edwards Lifesciences, LLC |
| Report date | Nov 9, 2022 |
| Recall initiation date | Oct 6, 2022 |
| Quantity | 26,560 units |
| Location | Irvine, CA, United States |
Official product description
Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP
Why the product was recalled
Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.
Distribution information
Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Albania, Argentina, Australia, Austria, Bahamas, Bahrain, Belgium, Bulgaria, CANARY ISLANDS, Chile, Colombia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Guam, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Lebanon, Malaysia, Malta, Mauritius, Morocco, Netherlands, Nicaragua, Northern Ireland, Oman, Panama, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates (UAE), United Kingdom.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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