The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product (Include the following information)
- Product Names: Custom Convenience Kits containing the Cardinal Health Monoject Flush Prefilled Syringe including: Leaderflex Insertion Kit with Ultrasound, Insertion Tray-RX, Universal Procedure Pack with Split Drape, Port Insertion Pack, and Procedure Pack
- Product Codes: See Recall Database Entry
- Model Numbers: AMS-9041CP, AMS-9046CP-1, AMS8939A, AMS9957A, and AMS12149
- Distribution Dates: January 23, 2020 to October 19, 2020
- Devices Recalled in the U.S.: 9,378
- Date Initiated by Firm: August 19, 2021
Aligned Medical Solutions has packaged the Cardinal Health Monoject Flush Prefilled Syringe (0.9% Sodium Chloride) in a convenient manner for use in a general clinical procedure. All other components in the kit are not affected by this recall.
Reason for Recall
Aligned Medical Solutions is recalling its custom convenience kits due to the potential for the plunger of the Cardinal Health Monoject Flush Prefilled Syringe (0.9% Sodium Chloride) to draw back after the air has been expelled and reintroduce air back into the syringe.
If a clinician is not aware of air being reintroduced into the syringe, the clinician could inadvertently push air into the vascular system, creating the potential for an air embolism. The use of affected product may cause serious adverse health consequences, including death.
There have been 42 reports of plunger retraction and introduction of air into the Cardinal Health Monoject Flush Prefilled Syringe (0.9% Sodium Chloride). There have been no reports of complaints, injuries or deaths related to this device issue.
Who May Be Affected
- Health care providers using the affected Aligned Medical Solutions Custom Convenience Kits
- Patients receiving care using the affected Aligned Medical Solutions Custom Convenience Kits
What to Do
On August 19, 2021, Aligned Medical Solutions sent all affected customers an “Urgent Medical Device Recall” letter.
The letter requested customers to:
- Identify the affected products.
- Complete a recall reply form.
- Fax completed recall reply form to Aligned Medical Solutions at 407-804-8460 or email the completed form to firstname.lastname@example.org.
- Consumers can request replacement syringes by calling 407-638-9924.
Customers with questions about this recall should call Aligned Medical Solutions at 406-259-6387 or 407-865-7211.
- Medical Device Recall Database Entries
- Windstone Medical Packaging dba Aligned Medical Solutions Issues Nationwide Recall of Cardinal Health’s Monoject™ Flush Prefilled Saline Syringes placed into the following 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
- Cardinal Health announces a voluntary recall for select Monoject™ Flush Prefilled Saline Syringes (0.9% Sodium Chloride)
- Windstone Medical Packaging dba Aligned Medical Solutions Issues Nationwide Recall of Cardinal Health’s Monoject™ Flush Prefilled Saline Syringes in Kits Due to Plunger Defect
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.