CLASS II Device recall · Reported 4 Nov 2020 · FDA Enforcement Report
Instructions For Use document of the GPS Trackers recalled by Blue Ortho
Blue Ortho is recalling Instructions For Use document of the GPS Trackers, distributed in California, Colorado, South Carolina, Wisconsin. The recall was initiated on 10 Sep 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0288-2021
- FDA event ID
- 86491
- Recalling firm
- Blue Ortho, Gieres, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Sep 2020
- FDA classified
- 23 Oct 2020
- Reported
- 4 Nov 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 10 Sep 2020 | Recall initiated by company | |
| 23 Oct 2020 | Classified by FDA | +43 days |
| 4 Nov 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Instructions For Use document of the GPS Trackers.
Where it was distributed
Domestic Distribution Only: CA, CO, SC and WI.
Questions about this recall
Is Instructions For Use document of the GPS Trackers recalled?
Yes. Blue Ortho recalled Instructions For Use document of the GPS Trackers on 10 Sep 2020. The recall is Class II and its status is Terminated. Recall number Z-0288-2021.
Why was it recalled?
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.
Which lots are affected?
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, 08-0003-19, 05-0362-19, 02-0061-19, 08-0064-12, 05-0381-19, 02-0079-19, 02-0050-17, 01-0205-14, 05-0068-18, 04-0288-19, 02-0067-17, 02-0031-17, 02-0064-17, 10-0009-12, 07-0018-14, 02-0008-18, 02-0060-17, 01-0129-19, 02-0044-17, 04-0293-19, 05-0031-14, 05-0365-19, 06-0192-19, 08-0036-18, 10-0024-17, 10-0030-12, 12-0049-19, 12-0050-19, 12-0059-19, 12-0061-19, 06-0221-19, 02-0090-19, 02-0108-19, 06-0187-19, 06-0161-19, 04-0301-19, 01-0120-19. Model number: A100005 (Diamond T) Serial numbers for model A100005: 08-0080-16, 09-0032-16, 04-0108-13, 08-0088-16, 09-0028-16, 05-0223-13, 12-0123-18, 06-0041-19, 04-0085-19, 06-0438-18, 01-0232-19, 02-0176-19, 05-0185-14, 09-0022-16, 01-0223-19, 04-0167-16, 06-0564-12, 02-0170-19, 05-0057-14, 11-0100-13, 09-0025-16, 02-0120-17, 04-0119-13, 09-0026-16, 10-0085-12, 09-0020-16, 12-0101-18, 11-0074-19, 10-0079-12, 07-0040-19, 10-0167-19, 03-0048-19, 05-0191-14, 10-0082-12, 07-0251-14, 06-0109-17, 10-0175-19, 10-0040-19, 01-0222-19. Model number: A100006 (Diamond G) Serial numbers for model A100006: 08-0106-16, 08-0093-16, 01-0342-14, 08-0105-16, 08-0107-16, 09-0136-18, 12-0187-18, 05-0137-19, 04-0185-19, 06-0489-18, 05-0129-19, 06-0064-19, 02-0214-19, 06-0168-17, 11-0087-16, 07-0488-19, 05-0077-16, 02-0218-19, 06-0159-17, 01-0288-19, 02-0180-17, 06-0153-17, 05-0386-14, 03-0375-14, 06-0167-17, 06-0130-17, 11-0098-16, 02-0164-17, 05-0396-14, 06-0143-17, 07-0350-19, 10-0225-19, 03-0120-19, 07-0108-17, 01-0341-14, 10-0237-19, 07-0083-17, 10-0232-19, 05-0066-16. Model number: A100004 (Diamond F) Serial numbers for model A100004: 04-0013-19, 03-0336-14, 03-0083-14, 01-0014-15, 05-0066-19, 05-0154-14, 01-0200-19, 01-0203-19.
Where was it sold?
Domestic Distribution Only: CA, CO, SC and WI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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