Monoject 0 — Class I medical device recall Z-0119-2022
Ongoing recall by Windstone Medical Packaging, Inc., reported 2021-11-10, distributed in FL, PA. Monoject 0.9% Sodium Chloride Flush Syringe Manufactured by Cardinal Health and placed into kits. Potential fo
| Recall number | Z-0119-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Windstone Medical Packaging, Inc., Billings, MT, United States |
| Recall initiated | 2021-08-19 |
| Classified | 2021-10-29 |
| Reported by FDA | 2021-11-10 |
| Distributed | FL, PA |
| Quantity | 9,378 |
| Lot numbers | 136833, 137794, 140390, 141087, 141088, 141096, 141097, 141098, 141100, 141101, 141102, 141717, 145615, 145718, 146037, 146039, 146349, 146351, 146766, 146768, 146897, 146905, 146908, 147773, 147902, 147903, 148409, 148410, 148411, 148412, 148413, 148414, 148450, 148451, 148452, 148612, 148636, 148638, 148639, 148640 and 16 more |
| Model numbers | 136833, 8881570121, AMS-9041CP |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0119-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.