CLASS I ONGOING Device recall · Reported 1 Sep 2021 · FDA Enforcement Report
Monoject 0.9% Sodium Chloride Flush Syringe Fill, Sterile, Product recalled
Cardinal Health is recalling Monoject 0.9% Sodium Chloride Flush Syringe Fill, Sterile, distributed nationwide in the US. The recall was initiated on 4 Aug 2021 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2285-2021
- FDA event ID
- 88421
- Recalling firm
- Cardinal Health, Mansfield, MA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 4 Aug 2021
- FDA classified
- 21 Aug 2021
- Reported
- 1 Sep 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 4 Aug 2021 | Recall initiated by company | |
| 21 Aug 2021 | Classified by FDA | +17 days |
| 1 Sep 2021 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusetts
Questions about this recall
Why was it recalled?
Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
Which lots are affected?
20I1524 20D0694 20I1584
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 88421This product is part of a recall event; the main page for the event is Monoject 0.9% Sodium Chloride Flush Syringe Fill, Sterile, Product recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Monoject 0.9% Sodium Chloride Flush Syringe Fill, Sterile, Product recalled | Cardinal Health | Other | Nationwide | |
| CLASS I | Monoject 0.9% Sodium Chloride Flush Syringe Fill, Sterile, Product recalled | Cardinal Health | Other | Nationwide |
More recalls from Cardinal Health
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|---|---|---|---|---|---|
| Drug | CLASS II | Enoxaparin Sodium Injection, USP, 30 mg recalled by Cardinal HealthEnoxaparin Sodium | Cardinal Health | Packaging Defects | KS |
| Drug | CLASS II | Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector recalledXolair | Cardinal Health | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Xolair (omalizumab injection), 75 mg recalled by Cardinal HealthXolair | Cardinal Health | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Recombinate, [Antihemophilic Factor (Recombinant)] vials recalled | Cardinal Health | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Wegovy (semaglutide) injection recalled by Cardinal Health | Cardinal Health | Temperature Abuse | NC, SC, VA |
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|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |