FDA Device recall Z-0119-2022
Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121 inside the following Aligned Medical Solutions Custom Conven…
- FDA Device
- Class I
- ongoing
- Published 2021-11-10
On 2021-11-10 the FDA classified a Class I recall of Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121 inside the following Aligned Medical Solutions Custom Conven… by Windstone Medical Packaging, citing monoject 0.9% Sodium Chloride Flush Syringe Manufactured by Cardinal Health and placed into kits. Potential for the plunger to draw back after air has been expelled and reintroduc….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0119-2022 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2021-08-19 |
| Published | 2021-11-10 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Windstone Medical Packaging |
| Distribution | FL, PA |
Product
Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121 inside the following Aligned Medical Solutions Custom Convenience Kits: AMS-9041CP Leaderflex Insertion Kit with Ultrasound, AMS-9046CP-1 Insertion Tray-RX, AMS8939A Universal Procedure Pack w/Split Drape, AMS9957A Port Insertion Pack, and AMS12149 Procedure Pack
Reason
Monoject 0.9% Sodium Chloride Flush Syringe Manufactured by Cardinal Health and placed into kits. Potential for the plunger to draw back after air has been expelled and reintroduce air back into the syringe.
Identifiers
| code_info | Syringe Lots: All Lots manufactured and distributed between July 1, 2019 and July 2021. Kit Model/Lots: AMS-9041CP…Syringe Lots: All Lots manufactured and distributed between July 1, 2019 and July 2021. Kit Model/Lots: AMS-9041CP/ 136833; AMS-9046CP-1/ 137794; AMS8939A/ 140390, 141088, 141096, 141100, 141102, 146039, 146349, 147902, 147903, 148414, 148452, 148640, 149132, 149135, 149485, 141087, 141097, 145615, 146351, 146766, 146768, 146905, 146908, 148638, 149137, 149138, 149484, 149486, 141101, 148410, 148411, 148639, 149133, 141098, 146037, 148409, 148413, 148450, 149131, 149134, 149136, 148412, 148451, 148636, 141717 AMS9957A/ 147773; AMS12149/ 145718, 146897, 148612 |
|---|
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-0119-2022%22
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