Recall Z-2058-2017— Stryker Medical Division of Stryker Corporation

Name: FDA recall Z-2058-2017
Creator: U.S. Food and Drug Administration
Published: 2017-03-29

Class II · Terminated

Class II FDA medical device recall by Stryker Medical Division of Stryker Corporation, initiated 2017-03-29, terminated 2017-09-18. It names one FDA 510(k) clearance: K912051. Product: Medi-Therm Hyper/Hypothermia System, MTA7900. Reason: The water may reheat too quickly if the unit is in "Automatic" mode, switched to "Manual" mode to view water temperature, and then switched back to "Automatic" mode..

Recalling firm: Stryker Medical Division of Stryker Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-03-29
Terminated: 2017-09-18
Firm location: Portage, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K912051 — MEDI-THERM (MTA-5900) & DETACHABLE HOSESGaymar Industries, Inc.·cleared 1991-07-30

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

Medi-Therm Hyper/Hypothermia System, MTA7900

Reason for recall

The water may reheat too quickly if the unit is in "Automatic" mode, switched to "Manual" mode to view water temperature, and then switched back to "Automatic" mode.

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