FDA MedWatch - Select Monoject Flush Prefilled Saline Syringes By Cardinal Health: Recall

Products have been found to reintroduce air into the syringe after the air has been expelled

MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Select Monoject Flush Prefilled Saline Syringes By Cardinal Health: Recall - Products have been found to reintroduce air into the syringe after the air has been expelled AUDIENCE: Patient, Health Professional, Risk Manager, Pharmacy ISSUE: On August 4, 2021, Cardinal Health initiated a nationwide recall of approximately 267 million Monoject Flush Prefilled Saline Syringes (0.9% Sodium Chloride). The products have been found to reintroduce air into the syringe after the air has been expelled. This could result in injection of air into blood vessels and create the potential for air embolism, which can cause serious adverse health outcomes or death. The company has received 37 reports of the plunger pulling back. No injuries have been reported to date. For more information about this recall, including the affected products and SKUs, click on the red button "Read Recall" below. BACKGROUND: Monoject Flush Prefilled Saline Syringes can be identified by the barrel of the syringe, the case and the box.    RECOMMENDATION: Customers who have affected product(s) should immediately review their inventory, quarantine and return all affected product.  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 form, or submit by fax to 1-800-FDA-0178.

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