FDAClass ISeptember 1, 2021

Monoject 0.9% Sodium Chloride Flush Syringe recall

Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code 8881570125 The proposed device is indicated for use in flushing…

Why was Monoject 0.9% Sodium Chloride Flush Syringe recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

20D0614 21D0894 20D0624 20D0674 20D0684 20H1504 20H1514

Product
Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code 8881570125 The proposed device is indicated for use in flushing…
Recalling firm
Cardinal Health
Quantity
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.
Recall date
September 1, 2021
Classification
Class I
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls