Propel Mini Mometasone Furoate Sinus Implant recall
Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044
Why was Propel Mini Mometasone Furoate Sinus Implant recalled?
Sinus Implant product label displays incorrect product information including: "Straight Delivery System", with incorrect reference number and UDI-DI.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
REF: 60044, UDI-DI: M927600440, Lot: 22041901
- Product
- Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044
- Recalling firm
- Intersect ENT, Inc.
- Quantity
- 611 units
- 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.
- Recall date
- December 14, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)