Stryker T/Pump Temperature Therapy Pumps Recalled for Manual Error
Stryker is recalling T/Pump temperature therapy pumps because the operations and maintenance manuals incorrectly added a sentence to the Indications for Use statement.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the violation is not likely to cause adverse health consequences. The issue is a documentation error in the manuals rather than a functional defect in the device itself.
Plain-English summary
Stryker Medical Division of Stryker Corporation is recalling 9,902 units of the T/Pump temperature therapy pump, Models TP700 and TP700C. The recall was initiated because 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.
The affected devices were distributed in all 50 states, the District of Columbia, and Guam. The source text does not specify the dates of distribution or the specific facilities where the devices are located.
Consumers and healthcare facilities should check their inventory for the specific serial numbers listed in the official recall notice. If a device is found, it should be removed from service and returned to Stryker for correction of the manual documentation.
The recalled product
- Product
- T/Pump temperature therapy pump, Models TP700 and TP700C
- Manufacturer
- Stryker Medical Division of Stryker Corporation
- Hazard
- Affected units
- 9,902
Distribution
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