Monoject 0.9% Sodium Chloride Flush Syringe, 3 mL Fill, STERILE, Product Code 8881570123 The proposed device is indi
Summary
The FDA issued a Class I for Monoject 0.9% Sodium Chloride Flush Syringe, 3 mL Fill, STERILE, Product Code 88 by Cardinal Health. Reason: Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe..
Details
Source
Device Recall
External ID
Z-2285-2021
Action Date
2021-09-01
Status
Ongoing
Category
device
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.
Lot/Code Info: 20I1524 20D0694 20I1584
Quantity Affected: 267,217,860 eaches in total
Reason for Recall
Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-04
Company
Mansfield, MA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 155 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Cardinal Health has 20 FDA actions in our database, including 20 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Cardinal Health) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cardinal Health have FDA actions?
Cardinal Health has 20 FDA actions in our database, including 20 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2285-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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