Device product
regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 335576REG - Product Usage: The integrating indicator is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance.
Z-2699-2020
Product summary
- Event
- Event 85907
- Status
- Terminated
- Classification
- Class II
- Quantity
- 66 cases of 12,000 units per case
- Official record key
device-enforcement:Z-2699-2020
Official wording
Reason: The firm received reports from customer that the Regard Migrating Indicator shown malfunctions and does not go into the "accept" window at the time of use.
Code information: Lot 719
Distribution pattern: US Nationwide distribution including in the states of MO, NC, AR, OK.
Derived failure modes
-
Unknown
The firm received reports from customer that the Regard Migrating Indicator shown malfunctions and does not go into the "accept" window at the time of use.