FDA recall Z-0288-2021

Product

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.

Distribution

Domestic Distribution Only: CA, CO, SC and WI.

Key facts

Status

Terminated

Initiation date

2020-09-10

Report date

2020-11-04

Termination date

2023-05-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Gieres, N/A, France

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0288-2021