FDA Device recall Z-2285-2021
Monoject 0.9% Sodium Chloride Flush Syringe, 3 mL Fill, STERILE, Product Code 8881570123 The proposed device is indicated for use in flushi…
- FDA Device
- Class I
- ongoing
- Published 2021-09-01
On 2021-09-01 the FDA classified a Class I recall of Monoject 0.9% Sodium Chloride Flush Syringe, 3 mL Fill, STERILE, Product Code 8881570123 The proposed device is indicated for use in flushi… by Cardinal Health, citing potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2285-2021 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2021-08-04 |
| Published | 2021-09-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Cardinal Health |
| Distribution | US |
Product
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.
Reason
Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
Identifiers
| code_info | 20I1524 20D0694 20I1584 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2285-2021%22
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