Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044
- Company
- Intersect Ent, Inc.
- Recall Initiated
- October 21, 2022
- Posted
- December 8, 2022
- Recall Number
- Z-0458-2023
- Quantity
- 611 units
- Firm Location
- Menlo Park, CA
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.
Lot / Code Info
REF: 60044, UDI-DI: M927600440, Lot: 22041901
Root Cause
Error in labeling
Action Taken
On 10/21/22, recall notices from Medtronic/Intersect ENT were sent to customers who were asked to do the following: 1) Identify, quarantine, and return all unused affected products to Medtronic. 2) Complete and return the customer confirmation form. 3) Distribute the recall notice to all others in your organization who should be aware, or to any organization where the potentially affected devices have been transferred. The following contact information was provided: rs.xentproductfeedback@medtronic.com and CustomerService@intersectent.com