Product Safety Recalls

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Saranas, Inc. Recall 90725

Description: Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)

Saranas, Inc. Recall 90725 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1684-2022
Event ID90725
Event DescriptionEarly Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)
Product TypeDevices
DistributionUS Nationwide distribution including in the states of PA, MI, FL, WV, TX, NJ, GA, LA, NY, MA, CT, AZ, OH, TN, VA.
Quantity953
Recall ReasonBleed monitoring system device design error, causing the device to not power on and complete the series of self-tests so instructions for use being updated to include device check before use ensure that the device is functioning appropriately.
Device Classification20220914
Device Code InfoUDI/REF/Lot: 00866532000402/FG001-01/510090S, 511110A, 510120F, 102422, 102445, 102531, 102671, 102685, 102731; 00866532000419/FG001-02/515070A, 528090C, 510120G, 511110B, 102567, 102610, 102611
Center Classification Date20220907
Recall Initiation Date20220810
Recalling FirmSaranas, Inc.
Initial Notification Letter
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