Intersect ENT, Inc. recalls Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044
- Recall date
- October 21, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0458-2023
- FDA classification
- Class II
- Brand / firm
- Intersect ENT, Inc.
- Sold / distributed
- US Nationwide distribution including in the states of NC, IL, KS, OR, WI, TX, FL, MN, WY, UT, NY, CA, NJ, OK, MD, HI, MT, TN, MO, IA, MA, AZ, GA, LA, ID, SC, WA, SD, ND, CO, NV.
Why it was recalled
Sinus Implant product label displays incorrect product information including: "Straight Delivery System", with incorrect reference number and UDI-DI.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044
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