Embolism Risk: Cardinal Health Monoject Syringe

IPSIS Patient Safety Alert 08/23/2021: Cardinal Health Recalls Monoject Saline Flush Prefilled Syringes for Risk of Air Re-entering Syringe Leading to Air Embolism

This is an important alert from the International Pain and Spine Intervention Society. IPSIS sends Patient Safety Alerts when it receives important information regarding products or services that can impact your patients' safety. When the Food and Drug Administration (FDA) issues a safety alert, or a company announces a recall or market withdrawal, the FDA posts the announcement as a public service. In such cases neither IPSIS nor the FDA endorse either the product or the company.

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.

ISSUE: Cardinal Health is recalling three models of Monoject Saline Flush Prefilled Syringes because it is possible the syringe’s plunger may pull air into the syringe after the health care provider has pushed out (expelled) the air. The materials used to make the syringe let the plunger slip back in the syringe. If air is injected into blood vessels, it can block the vessel (air embolism). Air embolisms can result in serious adverse health consequences, including stroke or death.

There have been 37 complaints, no injuries, and no deaths reported for this issue.

Click here for more information about this recall.

BACKGROUND: Monoject Saline Flush Prefilled Syringes are used to flush out many different types of intravenous (IV) tubing and other devices that give health care workers access to the blood vessels (intravascular access devices) for fluid and medication delivery. These syringes are prefilled with preservative-free saline in various sizes and different amounts of saline (volumes). They are disposable and used one time only.

RECOMMENDATION: On August 4, 2021, Cardinal Health issued an Urgent Medical Device Recall letter to customers with the following instructions:

• Review inventory for the affected product.
• Separate the affected product on-hand from other products.
• Share this information with clinical staff through safety huddles to ensure awareness.
  
• Return an acknowledgement form provided with the letter, whether or not there is affected product in the facility.
• Contact the appropriate customer service group to arrange for return and credit of affected product, if product was received directly from Cardinal Health.
  
  • Hospital customers: 800-964-5227
  • Federal government customers: 800-444-1166
    
  • Distributors: 800-635-6021
  • All other customers: 888-444-5440
    

Contact the location where these products were purchased if they were not purchased directly from Cardinal Health.

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 Adverse Event Reporting Program :

• Complete and submit the report online ; or
• Download and complete the form , then submit it via fax at 1-800-FDA-0178
  

Source: Food and Drug Administration - Accessed 08/23/2021