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Recall Observatory FDA recall evidence

Device product

Monoject 0.9% Sodium Chloride Flush Syringe, 3 mL Fill, STERILE, Product Code 8881570123 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.

Z-2285-2021

August 04, 2021

Class I

Product summary

Firm
Cardinal Health
Event
Event 88421
Status
Ongoing
Classification
Class I
Quantity
267,217,860 eaches in total
Official record key
device-enforcement:Z-2285-2021

Official wording

Reason: Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.

Code information: 20I1524 20D0694 20I1584

Distribution pattern: US 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.

Field note

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