Recall Z-2699-2020 ยท JOJ Indicator, Physical/Chemical Sterilization Process
Resource Optimization & Innovation LLC
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.
| Date | Jun 17, 2020 |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | The firm initiated the recall by email on 06/17/2020. The letter requested the customer quarantine any product and notify the firm. ROi, LLC will facility the return of the product. The letter also directed the customer notify all potential users how may have received the recalled item. |
| Quantity | 66 cases of 12,000 units per case |
| Distribution | US Nationwide distribution including in the states of MO, NC, AR, OK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982188 | STERI-PAK BOWIE DICK TEST PACK Steritec Products Mfg Co, Inc., Nov 20, 1998 |