Propel Mini Sinus Implant Recalled for Incorrect Product Label Information
Intersect ENT is recalling 611 units of Propel Mini Mometasone Furoate Sinus Implant due to incorrect product identification information on the label. The label displays wrong reference numbers and UDI-DI codes.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a FDA Class II medical device recall where critical product identification information (reference number and UDI-DI codes) is incorrectly displayed on the product label. While no injuries or illnesses have been reported, incorrect labeling of medical devices poses a risk of device misidentification in clinical use and compromises device traceability.
Plain-English summary
Intersect ENT, Inc. is recalling 611 units of the Propel Mini Mometasone Furoate Sinus Implant with Straight Delivery System (REF 60044, Lot 22041901) due to incorrect product information displayed on the product label. The label shows incorrect reference numbers and UDI-DI identification codes, which are essential for proper device identification and traceability.
The recalled units were distributed nationwide across the United States, including North Carolina, Illinois, Kansas, Oregon, Wisconsin, Texas, Florida, Minnesota, Wyoming, Utah, New York, California, New Jersey, Oklahoma, Maryland, Hawaii, Montana, Tennessee, Missouri, Iowa, Massachusetts, Arizona, Georgia, Louisiana, Idaho, South Carolina, Washington, South Dakota, North Dakota, Colorado, and Nevada.
Patients and healthcare providers who have received this device should contact Intersect ENT for further instructions. Accurate product identification is critical in medical device use for proper clinical documentation, device tracking, and ensuring correct product specifications are followed.
The recalled product
- Product
- Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044
- Manufacturer
- Intersect ENT, Inc.
- Category
- Medical Device — Sinus Implant
- Affected units
- 611
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- REF: 60044
- UDI-DI: M927600440
- Lot: 22041901
Distribution
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