Recall Z-1013-2018 ยท ILO Pack, Hot Or Cold, Water Circulating
Stryker Medical Division of Stryker Corporation
T/Pump temperature therapy pump, Models TP700 and TP700C
| Date | Mar 14, 2018 (initiated Nov 7, 2017) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Error in labeling |
| Action | 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 loa |
| Quantity | 9902 |
| Distribution | Distributed in all 50 states, the District of Columbia, and Guam. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073675 | T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP Gaymar Industries, Inc., May 8, 2008 |