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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

StatusCompleted
Mandated?Voluntary: Firm initiated
Recall NumberZ-1407-2022
Event ID90492
Event DescriptionNonsterile 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 TypeDevices
DistributionDistribution was made to MO. There was no foreign/military/government distribution.
Quantity86 kits
Recall ReasonSome nonsterile components that were supposed to be sterile were packaged in nonsterile kits.
Device Classification20220727
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 Date20220719
Recall Initiation Date20220603
Recalling FirmROi CPS LLC
Initial Notification Telephone
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