FDA Device recall Z-2286-2021
Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code 8881570125 The proposed device is indicated for use in flushin…
- 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, 5mL Fill, STERILE, Product Code 8881570125 The proposed device is indicated for use in flushin… 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-2286-2021 |
| 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, 5mL Fill, STERILE, Product Code 8881570125 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 | 20D0614 21D0894 20D0624 20D0674 20D0684 20H1504 20H1514 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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FDA Drug · Class II · 2025-08-13 · Cardinal Health - Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens per Carton, For Subcutaneous Use Only, Rx Only, Single-Dose On…
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2286-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.