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.
Reported: August 5, 2020 Initiated: June 17, 2020 #Z-2699-2020
Product Description
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.
Reason for Recall
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.
Details
- Recalling Firm
- Resource Optimization & Innovation LLC
- Units Affected
- 66 cases of 12,000 units per case
- Distribution
- US Nationwide distribution including in the states of MO, NC, AR, OK.
- Location
- Saint Louis, MO
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Resource Optimization & Innovation LLC. Units affected: 66 cases of 12,000 units per case.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 5, 2020. Severity: Moderate. Recall number: Z-2699-2020.
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