Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0119-2022 — 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

U.S. FDA — Device Enforcement · United States · 2021-08-19 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0119-2022
Date of alert: 2021-08-19
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Windstone Medical Packaging, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 8881570121

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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