CBER Issues Update on Blood Bag Shortage

The Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) recently updated information related to a shortage of blood bags manufactured by Fenwal, Inc., that began in January 2022.

Fenwal informed FDA that due to manufacturing problems and quality procedures at Fenwal manufacturing facilities, including global supply chain issues related to the lack of some materials and components needed for the manufacturing process, the products listed in this notice may be in short supply and/or shortage until further notice.

The affected categories and products include the following:

• Blood-pack units with CPDA-1 and RS-2000 whole blood leukoreduction filter.
• Blood-pack units with anticoagulant citrate dextrose (ACD) solution.
• Blood-pack units with anticoagulant citrate phosphate dextrose (CPD) solution.
• Blood-pack units with anticoagulant CPD solution and Adsol red cell preservation solution.
• InterSol Solution NDC (Number 0942-9602-12).
• All solution subassemblies for use in further manufacture of apheresis kits, including ACD-A, Adsol, Saline – Alyx kits and ACD-A, Saline – Amicus Kits.

In addition, Fenwal stated that shortages of ingredients, components and manufacturing supplies, and release timing issues are intermittent and unpredictable. Accordingly, Fenwal may place these products on allocation as necessary to manage reduced or unavailable supply.