FDA Device recall Z-2284-2021
Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Code 8881570121 The proposed device is indicated for use in flush…
- 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, 10 mL Fill, STERILE, Product Code 8881570121 The proposed device is indicated for use in flush… 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-2284-2021 |
| 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, 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
Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
Identifiers
| code_info | 19G0814 19G0824 19G0834 19G0844 19G0854 19G0864 19G0874 19G0894 19H0914 19H0924 19H0934 19H0944 19H0954 19…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 2 |
|---|
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-2284-2021%22
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