Blue Ortho Recalls GPS Tracker Instructions Due to Sterilization Language
Blue Ortho is recalling 3,471 GPS Tracker Instructions For Use documents because some low-temperature sterilization conditions were approved based on rational documents.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving documentation and labeling issues regarding sterilization instructions. No injuries or illnesses have been reported, and the hazard is related to the appropriateness of the language used rather than a direct physical defect in the device itself.
Plain-English summary
Blue Ortho is recalling 3,471 units of Instructions For Use (IFU) documents for its GPS Trackers. The recall involves specific model numbers A100003, A100004, A100005, and A100006, with serial numbers listed in the agency's structured data. The affected documents were distributed domestically in California, Colorado, South Carolina, and Wisconsin.
The reason for the recall is the appropriateness of the language used in the tracker reprocessing instructions. Specifically, some low-temperature sterilization conditions mentioned in the IFUs are approved based on rational documents rather than standard validation methods. This classification is designated as Class II by the FDA.
No illnesses or injuries have been reported in connection with this recall. Consumers and healthcare facilities should check their inventory for the specific model and serial numbers listed in the recall notice and contact Blue Ortho for instructions on how to proceed.
The recalled product
- Product
- Instructions For Use document of the GPS Trackers.
- Manufacturer
- Blue Ortho
- Category
- Medical Device — Documentation
- Affected units
- 3,471
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model number: A100003 (Probe) Serial numbers for model A100003: 02-0200-17
- 01-0034-19
- 02-0097-19
- 06-0160-19
- 06-0168-19
- 11-0083-18
- 01-0072-19
- 01-0216-14
- 02-0091-19
- 02-0195-17
- 12-0040-15
- 02-0192-17
- 02-0199-17
- 10-0021-12
- 08-0028-19
- 02-0104-19
- 08-0017-19
- 05-0380-19
- 05-0371-19
- 08-0026-19
Distribution
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