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Monoject Flush Prefilled Saline Syringes by Aligned Medical Solutions: Recall – Due to Potential for Plunger to Draw Back After Air Has Been Expelled and Reintroduce Air Back into Syringe

Read the full press release from the FDA

Issue:

Aligned Medical Solutions is recalling Cardinal Health鈥檚 Monoject Flush Prefilled Saline Syringes placed into 9,378 kits. Including;

  • 1 lot of AMS-9041CP Leaderflex Insertion Kit with Ultrasound
  • 1 lot of AMS-9046CP-1 Insertion Tray-RX
  • 45 lots of AMS8939A Universal Procedure Pack w/Split Drape
  • 1 lot of AMS9957A Port Insertion Pack
  • 3 lots of AMS12149 Procedure Pack

These convenience kits contain the Cardinal Health鈥檚 Monoject Flush Prefilled Saline Syringe part # 8881570121, which has been recalled for the potential for the plunger to draw back after the air has been expelled and reintroduced air back into the syringe. If a clinician is not aware of air being introduced into the syringe, the clinician could inadvertently push air into the vascular system creating the potential for an air embolism which can result in serious adverse health consequences or death.

No injuries have been reported to date.

Background:

Monoject Flush Prefilled Saline Syringes鈥(0.9% Sodium鈥疌hloride),鈥痑re intended for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.

Recommendations:

Consumers who have affected product(s) should immediately review their inventory and quarantine all affected kits.

Consumers can request replacement syringes by calling the company.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report online.

Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.


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