FDA Device

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

Hazard

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.

What You Should Do

Remedy

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

Products

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 Ultras
Brand
Windstone Medical Packaging, Inc.
UPC
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

Units Affected

9,378