Class 1 Device Recall Custom Convenience Kits

• Date Initiated by Firm: August 19, 2021
• Create Date: October 29, 2021
• Recall Status: Open, Classified
• Recall Number: Z-0119-2022
• Recall Event ID: 88802
• 510(K)Number: K032438
• Product Classification: Saline, vascular access flush - Product Code NGT
• 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
• Code Information: 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
• Recalling Firm/ Manufacturer: Windstone Medical Packaging, Inc.; 1602 4th Ave N; Billings MT 59101-1521
• For Additional Information Contact: 406-259-6387
• Manufacturer 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.
• FDA Determined 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = NGT and Original Applicant = TYCO HEALTHCARE