Recall Z-1013-2018
Stryker Medical Division of Stryker Corporation · initiated November 7, 2017
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
T/Pump temperature therapy pump, Models TP700 and TP700C
Codes / lots: 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 TP700A61821 TP700A61823 TP700A61824 TP700A61829 TP700A61831 TP700A61837 TP700A61839 TP700A61842 TP700A61844 TP700CH51108 TP700A61654 TP700A61695 TP700A61696 TP700A61697 TP700A61700 TP700A61702 TP700A61704 TP700A61798 TP700A61817 TP700A61819 TP700A61820 TP700A61827 TP700A61828 TP700A61830 TP700A61832 TP700A61834 TP700A61835 TP700A61840 TP700A61699 TP700A61701 TP700A61720 TP700A61723 TP700A61731 TP700A61733 TP700C61078 TP700C61308 TP700C61316 TP700C61504 TP700C61546 TP700C61548 TP700C61549 TP700C61552 TP700C61570 TP700C61582 TP700C61592 TP700C61611 TP700C61615 TP700C61617 TP700A61655 TP700A61657 TP700A61669 TP700A61671 TP700A61672 TP700A61673 TP700A61687 TP700A61694 TP700A61703 TP700A61705 TP700A61706 TP700A61707 TP700A61708 TP700A61709…
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.
FDA-determined cause: Error in labeling
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.
Details
- Recall number
- Z-1013-2018
- Initiated
- November 7, 2017
- Posted by FDA
- March 14, 2018
- Terminated
- April 9, 2019
- Product code
- ILO – Pack, Hot Or Cold, Water Circulating
- Quantity
- 9902
- Distribution
- Distributed in all 50 states, the District of Columbia, and Guam.
- Recalling firm
- Stryker Medical Division of Stryker Corporation, Portage, MI