FDA recall Z-1013-2018

Product

T/Pump temperature therapy pump, Models TP700 and TP700C

Reason for recall

The T/Pump Operations Manual and Maintenance Manual were incorrectly revised to add the sentence, Temperature therapy can also be for heat conservation for normothermia maintenance to the Indications for Use statement.

Distribution

Distributed in all 50 states, the District of Columbia, and Guam.

Key facts

Status

Terminated

Initiation date

2017-11-07

Report date

2018-03-21

Termination date

2019-04-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Portage, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1013-2018