Product Safety Recalls

Product Recall Tracker

Windstone Medical Packaging, Inc. Recall 88802

Description: 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

Windstone Medical Packaging, Inc. Recall 88802 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0119-2022
Event ID88802
Event DescriptionMonoject 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 TypeDevices
DistributionFL and PA
Quantity9,378
Recall ReasonMonoject 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.
Device Classification20211110
Device Code InfoSyringe 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
Center Classification Date20211029
Recall Initiation Date20210819
Recalling FirmWindstone Medical Packaging, Inc.
Initial Notification Letter
Similar To

© 2022 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied.
Recall.report is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.