Trackx Technology Inc: Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument us

Hazard

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.

Details from the source

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. Distribution: NC, VA, FL, PA, NY Quantity: 82 Lot/code info: GTIN: 00857088008493, Lot: 2404002, Expiration Date: 04/01/2027

UPC codes

00857088008493

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.