Instructions For Use document of the GPS Trackers.
This recall has been terminated (originally issued September 10, 2020).
- Recall Initiated
- September 10, 2020
- Terminated
- May 31, 2023
- Recall Number
- Z-0288-2021
- Quantity
- 3471 units
- Official Source
- View on FDA website ↗
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.
Distribution
Domestic Distribution Only: CA, CO, SC and WI.
Lot / Code Info
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.
Root Cause
Other
Action Taken
On 9/10/2020 the firm sent an Urgent Field Safety Notification to its consignees US FDA expressed concern with the 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, leveraged from proper validation files. Based on this concern, Blue Ortho decided to revise the appropriateness of the language used in the Tracker reprocessing instruction LEFUS Tracker for Low Temperature Sterilization v1.0 to remove such conditions. Blue Ortho has already updated the GPS Trackers IFUs, to remove the sterilizations cycle based on rational and not effectively supported by validation. The new version of the IFU is LEFUS Tracker for Low Temperature Sterilization v1.2 (version 1.1 has not been released to the field). The LEFUS Tracker for Low Temperature Sterilization v1.2 is enclosed to this notice. Transmission of this Field Safety Notice: " This notice needs to be passed on all those who need to be aware within your organization or to any organization where the potentially affected devices or documents have been transferred. " Please transfer this notice to other organizations on which this action has an impact. " Please maintain awareness on this notice.