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.
Reported: September 1, 2021 Initiated: August 4, 2021 #Z-2285-2021
Product Description
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.
Reason for Recall
Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
Details
- Recalling Firm
- Cardinal Health
- Units Affected
- 267,217,860 eaches in total
- Distribution
- 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.
- Location
- Mansfield, MA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Cardinal Health. Units affected: 267,217,860 eaches in total.
Why was this product recalled? ▼
Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 1, 2021. Severity: Critical. Recall number: Z-2285-2021.
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