Z-2286-2021 Class I Ongoing
FDA device recall Z-2286-2021 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, 5mL Fill, STERILE, Product Code 8881570125 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
20D0614 21D0894 20D0624 20D0674 20D0684 20H1504 20H1514