Recall Z-0288-2021— Blue Ortho

Name: FDA recall Z-0288-2021
Creator: U.S. Food and Drug Administration
Published: 2020-09-10

Class II · Terminated

Class II FDA medical device recall by Blue Ortho, initiated 2020-09-10, terminated 2023-05-31. It names one FDA 510(k) clearance: K193618. Product: Instructions For Use document of the GPS Trackers.. Reason: Appropriateness of the language used in the Tracker reprocessing instruction. Reason is that some Low Temperature sterilization conditions mentioned in the IFUs are approved based on rational documents..

Recalling firm: Blue Ortho
Classification: Class II
Status: Terminated
Initiated: 2020-09-10
Terminated: 2023-05-31
Firm location: Gieres, N/A, France

510(k) clearances named in this recall

1 on FDA's record

K193618 — ExactechGPS SystemBlue Ortho·cleared 2020-09-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Instructions For Use document of the GPS Trackers.

Reason for recall

Appropriateness of the language used in the Tracker reprocessing instruction. Reason is that some Low Temperature sterilization conditions mentioned in the IFUs are approved based on rational documents.

Data sourced from openFDA. This site is unofficial and independent of the FDA.