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
FDA Recall Z-0119-2022 · Posted None
Recalling FirmWindstone Medical Packaging, Inc.
Recall StatusOpen, Classified
Product CodeNGT
Date Initiated2021-08-19
Product Quantity9,378
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.
Firm 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
Root Cause
Device Design
Distribution Pattern
FL and PA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.