Reported Mar 21, 2018 · Terminated
T/Pump temperature therapy pump, Models TP700 and TP700C
Stryker Medical Division of Stryker Corporation
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Medical Division of Stryker Corporation · 3800 E Centre Ave · Portage, MI · 49002-5826
Is this the product you have?
- T/Pump temperature therapy pump, Models TP700 and TP700C
- Lot codes and dates
1,208 of 1,208 codes
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
- Amount recalled
- 9902
Where it was sold
- Nationwide
- DC
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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