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

    • 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
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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 9, 2019 · Data as of Sep 19, 4:44 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.