Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported September 1, 2021
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.
Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Cardinal Health recalled Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Code 8881570121… - a critical-severity action.
Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Code 8881570121… was recalled by Cardinal Health in September 1, 2021. Reason: Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syri…. Check the official notice for the remedy. Verify recall #Z-2284-2021 with the FDA Devices before acting.
The recall
Cardinal Health issued this critical-severity FDA Devices recall-Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syri….
- Critical
- severity level
- Class I
- classification
- September 1, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2284-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2284-2021) was formally reported on September 1, 2021, with the manufacturer initiating the action on August 4, 2021. It is classified under Critical severity (Class I), with a current status of Ongoing. Cardinal Health is listed as the recalling firm, operating out of Mansfield, MA. Federal records list the affected scope as 267,217,860 eaches in total.
The documented reason for this recall is: Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe. Distribution data in the federal record shows the product reached: 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, W…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
267,217,860 eaches in total
Related Recalls
6
3 from same agency
Product description
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.
Reason for recall
Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-2284-2021 |
| Date reported | September 1, 2021 |
| Date initiated | August 4, 2021 |
| Recalling firm | Cardinal Health |
| Firm location | Mansfield, MA |
| Affected scope | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2284-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was 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.. Recalled by Cardinal Health. Units affected: 267,217,860 eaches in total.
Why was this product recalled? ▼
Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 1, 2021. Severity: Critical. Recall number: Z-2284-2021.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2284-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 1, 2021. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.