Z-2285-2021 Class I Ongoing
FDA device recall Z-2285-2021 was initiated by Cardinal Health on August 4, 2021 and is designated Class I. Reason for recall: Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe. The recall status is ongoing. Affected quantity: 267,217,860 eaches in total.
Recall Details
- Product Type
- Devices
- Report Date
- September 1, 2021
- Initiation Date
- August 4, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 267,217,860 eaches in total
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.
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.
Code Information
20I1524 20D0694 20I1584