T/Pump temperature therapy pump, Models TP700 and TP700C

FDA device recall Z-1013-2018 · posted 2018-03-14 · Terminated

Recall details

Recalling firm

Stryker Medical Division of Stryker Corporation

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.

Action taken

The following actions are included in the consignee letter: 1. Locate the operations (101515 rev D.0) and maintenance (101176 rev F.0) manuals that accompanied the units listed on the attached business reply form. 2. Find the corrected pages included in this letter and insert one into each affected manual at your location. 3. Complete the enclosed business reply form to acknowledge that you have received and understand this notification. 4. Return your completed business reply form by fax 269 488 8691 or email productfieldaction@stryker.com to Strykers regulatory department. 5. If you have loaned or sold any of the products listed in this letter, please forward a copy of this notice to the new users and advise us of their new location in the space provided on the business reply form. 6. If you have disposed of any of these units and they are no longer in use, please, advise us of their obsolescence by providing us with their serial number in the space provided on the business reply form.

Root cause

Error in labeling

Status

Terminated

Product code

ILO

Quantity affected

9902

Distribution

Distributed in all 50 states, the District of Columbia, and Guam.

Date initiated

2017-11-07

Date posted

2018-03-14

Date terminated

2019-04-09

Location

Portage, MI

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