Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044
Summary
The FDA issued a Class II for Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF by Intersect ENT, Inc.. Reason: Sinus Implant product label displays incorrect product information including: "Straight Delivery System", with incorrect reference number and UDI-DI..
Details
Source
Device Recall
External ID
Z-0458-2023
Action Date
2022-12-14
Status
Ongoing
Category
device
Product Description
Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044
Lot/Code Info: REF: 60044, UDI-DI: M927600440, Lot: 22041901
Quantity Affected: 611 units
Reason for Recall
Sinus Implant product label displays incorrect product information including: "Straight Delivery System", with incorrect reference number and UDI-DI.
Distribution
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-10-21
Company
Menlo Park, CA
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 176 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Intersect ENT, Inc. has 2 FDA actions in our database, including 2 recalls.
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 (Intersect ENT, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Intersect ENT, Inc. have FDA actions?
Intersect ENT, Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0458-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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