Stryker Medical Division of Stryker Corporation recalls T/Pump temperature therapy pump, Models TP700 and TP700C

Recall date

November 7, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1013-2018

FDA classification

Class III

Brand / firm

Stryker Medical Division of Stryker Corporation

Sold / distributed

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

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

T/Pump temperature therapy pump, Models TP700 and TP700C