Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a sterile Snap that includes reflective feature
FDA device recall Z-0260-2025 · posted 2024-10-30 · Open, Classified
Recall details
- Recalling firm
- Trackx Technology Inc
- Reason for recall
- The patient label stickers may have the wrong expiration date recorded. The contract manufacturer entered the manufacturing date (2024-04-01) as the expiration date. The actual expiration date of the product is 2027-04-01. This is reflected on the carton label and sterile pouch label correctly.
- Action taken
- TrackX Technology issued an Urgent: Medical Device Field Correction notice to its consignees via hand delivery by their sales representatives on 10/01/2024. The notice explained the issue and requested that the notice be provided to all parties to whom the product was distributed. The sales representatives exchanged the affected product for correctly labeled product.
- Root cause
- Error in labeling
- Status
- Open, Classified
- Product code
- OWB
- Quantity affected
- 82
- Distribution
- NC, VA, FL, PA, NY
- Date initiated
- 2024-09-03
- Date posted
- 2024-10-30
- Location
- Hillsborough, NC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TrackX (K200360) | Track X Technology, LLC | 2020-03-05 |
| TrackX (K173736) | Track X Technology, LLC | 2018-02-28 |