FDA recall Z-0301-2018

Product

CER OPTION TYPE 1 TPR SLEVE -6, model # 650-1064

Reason for recall

Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.

Distribution

Nationwide in US; Internationally Argentina, Netherlands & Canada

Key facts

Status

Terminated

Initiation date

2017-06-05

Report date

2018-01-10

Termination date

2018-03-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0301-2018