Insight Base Flex - 8 recall
Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a sterile Snap that includes reflective features that facilitate imaging of…
Why was Insight Base Flex - 8 recalled?
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.
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?
GTIN: 00857088008493, Lot: 2404002, Expiration Date: 04/01/2027
- Product
- Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a sterile Snap that includes reflective features that facilitate imaging of…
- Recalling firm
- Trackx Technology Inc
- Quantity
- 82
- Distribution
- NC, VA, FL, PA, NY
- Recall date
- November 6, 2024
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (device)