Reported Nov 10, 2021 · Ongoing

Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121 inside the following Aligned Medical…

Windstone Medical Packaging, Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Windstone Medical Packaging, Inc. · 1602 4th Ave N · Billings, MT · 59101-1521

Is this the product you have?

    • Monoject 0.9% Sodium Chloride
    • Flush Prefilled Syringe
    • 10 mL
  • REF8881570121 inside the following Aligned Medical
  • Solutions Custom Convenience KitsAMS-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
Lot codes and dates

4 of 4 products · 50 lot codes

Recalled lot codes, grouped by product number
Kit ModelLots
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
Amount recalled
9,378

Where it was sold

Why it was recalled

Stop using this product now

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.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:54 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.