Use caution Medical device recall · FDA · Published August 19, 2021

Windstone Monoject Syringe Recall: Air Reintroduction Risk

Windstone Medical Packaging recalls Monoject 0.9% Sodium Chloride 10mL syringes in specific kits from July 2019-July 2021 due to potential air reintroduction after expelling air. Affected kits include AMS-9041CP, AMS-9046CP-1, and others with listed lot numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0119-2022Medical device Windstone Medical Packaging ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmWindstone Medical Packaging, Inc.1602 4th Ave N · Billings, MT 59101-1521

✎ GovInfoNow plain-language explainer

Windstone Medical Packaging recalls certain Monoject 0.9% Sodium Chloride 10mL syringes that came in specific medical kits from July 2019 to July 2021. The issue could cause air to be reintroduced into the syringe after expelling air, potentially affecting safe medical use. Read more at govinfonow.com/recall/61923-windstone-monoject-syringe-recall-air-reintroduction-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/61923-windstone-monoject-syringe-recall-air-reintroduction-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0119-2022

Cite this page

“Windstone Monoject Syringe Recall: Air Reintroduction Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61923-windstone-monoject-syringe-recall-air-reintroduction-risk. Based on FDA recall #Z-0119-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0119-2022%22&limit=1).

The FDA announced on 2021-08-19 that Windstone Medical Packaging, Inc. is recalling Monoject 0.9% Sodium Chloride Flush Prefilled Syringes due to a potential plunger issue. The agency classified the recall as Class I.

How to tell if you have it

Brand: Windstone Medical Packaging
Product: Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL
REF: 8881570121
Included in 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
Syringe Lots: All lots manufactured 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
Distribution: FL and PA

The hazard

The recall involves Monoject 0.9% Sodium Chloride Flush Syringes manufactured by Cardinal Health and placed into kits. The potential hazard is that the plunger may draw back after air has been expelled, reintroducing air back into the syringe.

Context

GovInfoNow's records show Windstone Medical Packaging, Inc. has 14 other recalls on record since 2017-10-24. Other recent recalls of similar products include Windstone AMS Convenience Kit with Blue Break-Off Parts Risk (2026-07-29), Windstone Medical Packaging Recall Due to Lidocaine Injection Quality Issues (2026-06-17), and Windstone Medical Neuro Pack Kits Recall for Potential Endotoxin Variability Risk (2026-06-08). Other recent recalls of similar products include Medline medical kits recall for Risk of syringe disconnection during use (2026-02-27), Medline Syringes Recall for 510(k) Clearances Rescinded for Safety (2026-02-25), and Medline Medical Convenience Kits Recall for Risk of Syringe Disconnection (2026-02-27).

How to tell if you have this one

Check for the syringe model number 8881570121 inside Aligned Medical Solutions kits labeled AMS-9041CP, AMS-9046CP-1, AMS8939A, AMS9957A, or AMS12149. The syringes were manufactured between July 2019 and July 2021.

Brand
Windstone Medical Packaging
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Syringe Model
Look for the syringe model number 8881570121 inside the specified Aligned Medical Solutions kits.
Contact Manufacturer
Contact Windstone Medical Packaging for confirmation of the recalled syringe model and kit.

Where it went and when

Where it was distributed

Distributed in Florida and Pennsylvania.

FDA distribution: “FL and PA” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Florida, Pennsylvania.

Recall timeline

FDA published this recall 3 months after the firm started it.

Aug 19, 2021Firm started the recall
Oct 29, 2021FDA classified it Class I
Nov 10, 2021Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

More Windstone Medical Packaging recalls

Link to this recall

<a href="https://govinfonow.com/recall/61923-windstone-monoject-syringe-recall-air-reintroduction-risk">Windstone Monoject Syringe Recall: Air Reintroduction Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0119-2022 (August 19, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0119-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.