Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE
Medical device recall Z-2284-2021. Published in FDA’s Enforcement Report on Sep 1, 2021.
- FDA Class I
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Sep 1, 2021. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 50 states named
- 267,217,860 eaches in total how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Code 8881570121 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.
267,217,860 eaches in total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
19G0814 19G0824 19G0834 19G0844 19G0854 19G0864 19G0874 19G0894 19H0914 19H0924 19H0934 19H0944 19H0954 19H0964 19H0974 19H0984 19H0994 19H1014 19H1004 19H1024 19I1034 19I1054 19I1074 19I1084 19I1104 19I1114 19I1134 19I1144 19I1154 19J1184…
Every code shown here, 2,000 characters
19G0814 19G0824 19G0834 19G0844 19G0854 19G0864 19G0874 19G0894 19H0914 19H0924 19H0934 19H0944 19H0954 19H0964 19H0974 19H0984 19H0994 19H1014 19H1004 19H1024 19I1034 19I1054 19I1074 19I1084 19I1104 19I1114 19I1134 19I1144 19I1154 19J1184 19J1194 19J1204 19J1234 19J1244 19J1254 19J1284 19J1294 19J1304 19K1354 19L1364 19L1374 19L1384 20A0014 20A0024 20A0064 20A0034 20A0044 20A0054 20A0074 20A0084 20A0094 20A0104 20A0114 20A0124 20A0154 20A0144 20A0164 20A0184 20A0194 20B0204 20B0214 20B0224 20B0244 20B0234 20B0254 20B0264 20B0294 20B0274 20B0284 20B0304 20B0344 20B0314 20B0324 20B0394 20C0374 20B0334 20B0354 20B0364 20C0384 20C0414 20C0424 20C0454 20C0434 20C0444 20C0474 20C0464 20C0404 20C0484 20C0494 20C0504 20C0514 20C0524 20C0534 20C0544 20C0554 20C0564 20C0574 20C0584 20D0594 20D0604 20D0634 20D0644 20D0654 20D0664 20D0704 20D0714 20D0724 21D1014 20D0734 20D0744 20D0754 20D0764 20D0774 20E0824 20E0834 20E0844 20E0854 20E0864 20E0874 20E0914 20E0884 20E0894 20E0904 20E0924 20E0934 20E0974 20E0984 20E0994 20F1004 20F1014 20F1024 20F1034 20F1044 20F1074 20F1084 20F1094 20F1104 20F1124 20F1174 20F1134 20F1144 20F1184 20F1154 20F1164 20F1194 20F1214 20F1224 20G1284 20G1234 20G1244 20G1254 20G1294 20G1264 20G1314 20G1334 20G1344 20H1304 20H1354 20H1364 20H1374 20H1384 20H1394 20H1414 20H1424 20H1404 20H1434 20H1444 20H1494 20H1454 20H1464 20H1474 20H1484 20H1534 20H1544 20I1554 20I1564 20I1574 20I1624 20I1634 20I1644 20I1654 20I1664 20I1674 20I1684 20I1694 20I1704 20I1714 20I1764 20I1774 20J1784 20J1794 20J1804 20J1824 20J1834 20J1844 20J1854 20J1864 20J1914 20J1924 20J1934 20J1944 20J1954 20J2074 19J1324 20J2084 19J1334 20J2094 20K2144 20K2104 20K2114 19K1344 20K2164 20K2154 20K2174 20K2184 20K2194 20K2204 20K2224 20K2264 20K2274 20K2234 20K2284 20K2294 20K2304 20K2404 20K2344 20K2414 20K2424 20L2394 20L2434 20L2484 20L2494 20L2504 20L2474 20L2514 20L2524 20L2564 20L2604 20L2614 20L2574 20L2624 20L2634 20L2644 21A0014 21A0024 21A0034 21A0044 21A0054 21A0114 21A0124…
FDA’s list runs to 2,479 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
50 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Aug 4, 2021.
- FDA classified it on Aug 21, 2021.
- FDA’s Enforcement Report published it on Sep 1, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Cardinal Health, of Mansfield, MA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 2,479 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.