FDA Device recall Z-1013-2018
T/Pump temperature therapy pump, Models TP700 and TP700C
- FDA Device
- Class III
- terminated
- Published 2018-03-21
On 2018-03-21 the FDA classified a Class III recall of T/Pump temperature therapy pump, Models TP700 and TP700C by Stryker Medical Division, citing 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 maintenanc….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1013-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-11-07 |
| Published | 2018-03-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Stryker Medical Division |
| Distribution | US |
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.
Identifiers
| code_info | TP700CI51006 TP700CI51013 TP700A61786 TP700A61803 TP700A61810…TP700CI51006 TP700CI51013 TP700A61786 TP700A61803 TP700A61810 TP700A61754 TP700A61794 TP700A61802 TP700A61808 TP700A61811 TP700A61822 TP700B61158 TP700B61018 TP700B61033 TP700B61121 TP700B61122 TP700B61128 TP700B61131 TP700B61133 TP700B61134 TP700B61135 TP700B61139 TP700B61140 TP700B61142 TP700B61145 TP700B61146 TP700B61152 TP700B61162 TP700CH51109 TP700CH51116 TP700CI51002 TP700A61807 TP700A61792 TP700A61804 TP700A61813 TP700A61814 TP700A61815 T |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1013-2018%22
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