FDA recall Z-0119-2022

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

Status

Ongoing

Initiation date

2021-08-19

Report date

2021-11-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Billings, MT, United States

Primary source

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