Stryker recalls T/Pump temperature therapy pumps (models TP700 and TP700C) due to incorrect manual updates adding 'heat conservation for normothermia maintenance' to indications. No immediate action needed as the hazard is a documentation error.
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.
Stryker is recalling temperature therapy pumps (TP700 and TP700C models) because their operation and maintenance manuals were incorrectly updated to include a sentence about using heat conservation for normothermia maintenance. This is a documentation error, not a safety hazard, so no action is required.
The hazard is a documentation error where the operation and maintenance manuals were incorrectly updated to add the phrase 'Temperature therapy can also be for heat conservation for normothermia maintenance' to the Indications for Use section. This does not affect the device's safety or function.
Medical professionals using Stryker's T/Pump temperature therapy pumps (models TP700 and TP700C) are likely affected. Patients using these devices are not at risk as the issue is a documentation error.
Check if your pump has a model number starting with TP700 or TP700C followed by a specific 6- or 7-digit code listed in the detailed product list. The recall covers multiple model variants.
Review your pump's model number to see if it matches the list of affected models provided in the recall notice.
No, this is a documentation error in the manuals. The device itself is safe to use as the hazard is only in the written instructions.
No action is required. The recall is for documentation correction only, not a safety issue.
The recall covers T/Pump temperature therapy pumps with model numbers starting with TP700 or TP700C followed by specific 6- or 7-digit codes listed in the detailed product list.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-1013-2018 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-1013-2018 from Stryker. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
