FDA Medical Device Recalls (openFDA)
Windstone Medical Packaging, Inc.: 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
- Recall number
- Z-0119-2022
- 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
- Status
- Open, Classified
- Initiated
- 2021-08-19
- Posted
- not on file
- Terminated
- not on file
- 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.
- 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
- 9,378
- Distribution
- FL and PA
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K032438"]
- PMA numbers
- not on file
- Product code
- NGT
- Firm FEI
- 1000125955
- Firm city
- Billings
- Firm state
- MT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28