Recall Z-1013-2018— Stryker Medical Division of Stryker Corporation
Class III · Terminated
Class III FDA medical device recall by Stryker Medical Division of Stryker Corporation, initiated 2017-11-07, terminated 2019-04-09. It names one FDA 510(k) clearance: K073675. Product: T/Pump temperature therapy pump, Models TP700 and TP700C. Reason: 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..
- Recalling firm
- Stryker Medical Division of Stryker Corporation
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2017-11-07
- Terminated
- 2019-04-09
- Firm location
- Portage, MI, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.