Blue Ortho recalls specific GPS Tracker models (A100003, A100004, A100005, A100006) due to potential language issues in reprocessing instructions. Affected units have listed serial numbers.
Appropriateness of the language used in the Tracker reprocessing instruction. Reason is that some Low Temperature sterilization conditions mentioned in the IFUs are approved based on rational documents.
Blue Ortho is recalling GPS Trackers with specific model numbers and serial numbers because the Instructions For Use document contains language that may not be appropriate for low-temperature sterilization procedures. This recall addresses potential confusion in following sterilization guidelines, though it does not pose an immediate safety risk.
The Instructions For Use document mentions low-temperature sterilization conditions that are approved based on rational documents, but the language used may not be clear or appropriate for certain users. This could lead to confusion when following sterilization procedures, especially in healthcare settings where precise instructions are critical.
Users of Blue Ortho GPS Trackers with model numbers A100003, A100004, A100005, or A100006 and the listed serial numbers are affected. Healthcare facilities using these devices for sterilization processes are most at risk due to potential misinterpretation of instructions.
Check your GPS Tracker for model numbers A100003, A100004, A100005, or A100006. The specific serial numbers listed in the recall record indicate which units are affected.
Identify your GPS Tracker's model number (A100003, A100004, A100005, or A100006) to determine if it is affected.
Compare your Tracker's serial number against the list provided in the recall to confirm if it is affected.
The recall is due to potential language issues in the Instructions For Use document that may not be appropriate for low-temperature sterilization procedures, which could cause confusion in following sterilization guidelines.
If your Tracker is listed in the recall, you should check the model and serial numbers to confirm if it is affected. No action is required if it is not on the list.
This recall addresses potential confusion in instructions, not an immediate safety risk. The hazard level is low risk as it does not involve physical harm or injury.
We’ve drafted a message you can send Blue Ortho to request your refund or repair — edit it as you like.
Subject: Recall Z-0288-2021 — Blue Ortho Blue Ortho Hello, I own a Blue Ortho that is covered by recall Z-0288-2021 from Blue Ortho. 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.
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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.
