News on a recent FDA recall affecting the inheritable blood disorder community.
NHF requests members of the inheritable blood disorders community be informed of a recent FDA recall involving Monoject™ Flush Prefilled Saline Syringes. Please see the below and discuss with your physician for more information. Patients who would like to submit their experience and/or concerns to the national advocacy organizations can do so by visiting The Patient Voice.
Information from the FDA:
On August 4, 2021, Cardinal Health initiated a voluntary recall for select Monoject™ Flush Prefilled Saline Syringes (0.9% Sodium Chloride), which are intended for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices. 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.
The following SKUs have been recalled:
12mL Syringe, 10 mL Saline Fill SKU – 8881570121
12mL Syringe, 3 mL Saline Fill SKU – 8881570123
12mL Syringe, 5 mL Saline Fill SKU – 8881570125
As of August 19, 2021, Cardinal Health has not received any reports of patient harm or injury related to this issue. Cardinal Health plans to continue to sell through the existing inventory of their Monoject™ 3 mL Syringe, 2.5 mL Saline Fill (SKU 8881570300) that is not affected by this recall. Customers who may have received affected products will receive a notification packet from Cardinal Health via FedEx starting on Thursday, August 5, 2021, and should follow the actions outlined in the packet.
Customers with questions may contact the Cardinal Health market action team via telephone at 800.292.9332 between the hours of 8 a.m. – 5 p.m. EST. Customers may also contact the team via email at GMB-FieldCorrectiveAction@cardinalhealth.com. For more information on the recall visit the Cardinal Health announcement here.
Source: National Hemophilia Foundation, August 2021