# FDA recall Z-0119-2022

> **Windstone Medical Packaging, Inc.** · Class I · device recall initiated 2021-08-19.

## 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

## 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.

## Distribution

FL and PA

## Key facts

- **Recall number:** Z-0119-2022
- **Recalling firm:** Windstone Medical Packaging, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-08-19
- **Report date:** 2021-11-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Billings, MT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0119-2022

## Citation

> AI Analytics. FDA recall Z-0119-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0119-2022. Source: US FDA. Licensed CC0.

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