Z-0119-2022Class I

Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121 inside the following Aligned...

Name: Z-0119-2022 Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121 inside the following Aligned...
Creator: Windstone Medical Packaging, Inc.
Published: 2021-08-19
License: https://open.fda.gov/license/

Windstone Medical Packaging, Inc. / initiated 2021-08-19 / Open, Classified / root cause: design

FDA source

Windstone Medical Packaging, Inc. began a recall of Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121 inside the following Aligned Medical Solutions Custom Convenience Kits... on 2021-08-19. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0119-2022
Classification: Class I
Status: Open, Classified
Initiated: 2021-08-19
Posted: 2021-10-29
Recalling firm: Windstone Medical Packaging, Inc.
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
Product code: NGT Saline, Vascular Access Flush
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.
Root cause tag: design
FDA root cause: Device Design
Action: On 08/19/2021, recall notices were emailed to customers. Customers were asked to do the following: Identify remaining affected kits and follow the over-labeling instructions. The sticker should be placed in such a way that it would be immediately noticed but should not cover up or conceal any pertinent information such as Pack Number, Pack Name, Lot Number or Expiration Date. Sticker states in part: A recall of the prefilled syringe contained in this kit was announced. All other kit components are not affected. 1. At the time the kit is opened for use any prefilled syringe manufactured by Cardinal Health should be identified and set aside 2. The recalled syringe should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution. Complete and return the reply form. If product was further distributed, notify your customers of the product recall Customers with questions or concerns can contact the recalling firm at 407-638-9924, www.alignedmedicalsolutions.com There is a recall notice on the website: http://www.alignedmedicalsolutions.com/ams_recall_08192021.htm
Quantity in commerce: 9,378
Distribution: FL and PA
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0119-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0119-2022	Class I	Ongoing	Voluntary: Firm initiated	2021-11-10	2021-10-29

Product code NGT

K032438Class IIModification to: Monojet Prefill 0.9% Sodium Chloride Flush Syringe, Monojet Prefill Heprin Lock Flush SyringeTyco Healthcare / cleared 2004-06-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)