ROi CPS LLC Recall 90492
Description: Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle Mercy St Anthony; and (2) regard Item #830019017, CV00214Q - Dr Chauvin CV - Rogers.
ROi CPS LLC Recall 90492 Information
Status | Completed |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-1407-2022 |
Event ID | 90492 |
Event Description | Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle Mercy St Anthony; and (2) regard Item #830019017, CV00214Q - Dr Chauvin CV - Rogers. |
Product Type | Devices |
Distribution | Distribution was made to MO. There was no foreign/military/government distribution. |
Quantity | 86 kits |
Recall Reason | Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits. |
Device Classification | 20220727 |
Device Code Info | (1) Item #830099008 - Lot #92534, exp. 11/13/2022, UDI #10194717114895; (2) Item #830019017 - Lot #92612, exp. 8/31/2023, UDI #10194717113249. |
Center Classification Date | 20220719 |
Recall Initiation Date | 20220603 |
Recalling Firm | ROi CPS LLC |
Initial Notification | Telephone |
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