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Cardinal Health Recall 88421

Description: Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code 8881570125 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.

Cardinal Health Recall 88421 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2286-2021
Event ID88421
Event DescriptionMonoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code 8881570125 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.
Product TypeDevices
DistributionUS Nationwide Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY.
Quantity267,217,860 eaches in total
Recall ReasonPotential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
Device Classification20210901
Device Code Info20D0614 21D0894 20D0624 20D0674 20D0684 20H1504 20H1514
Center Classification Date20210821
Recall Initiation Date20210804
Recalling FirmCardinal Health
Initial Notification Letter
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