Device product
Instructions For Use document of the GPS Trackers.
Z-0288-2021
Product summary
- Firm
- Blue Ortho
- Event
- Event 86491
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3471 units
- Official record key
device-enforcement:Z-0288-2021
Official wording
Reason: 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.
Code information: 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.
Distribution pattern: Domestic Distribution Only: CA, CO, SC and WI.
Derived failure modes
-
Unknown
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.