B. Braun Recalls Certain Lots of Blood Administration Sets
Because of the potential for leakage at the joint between the blood filters and tubing, B. Braun issued a voluntary recall (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/b-braun-medical-inc-issues-voluntary-nationwide-recall-twenty-two-22-lots-blood-administration-sets) of 22 lots of its y-type blood administration sets in November 2019. The recalled sets are used to deliver blood from a container to a patient's vascular system through an IV catheter inserted into a vein or central venous catheter.
The concern about the leakage is twofold: leakage may result in delay in therapy because of the need to replace the set and blood product, or it may introduce the potential for microorganisms to enter the circulatory system, creating a risk of bloodstream infection. To date, no serious injuries or deaths have been reported.
The recall affects 43,026 blood administration set units that were manufactured from June 11–August 23, 2019, and distributed in the United States and Canada from June 11–September 27, 2019. For a complete listing of the affected lots, view the recall page (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/b-braun-medical-inc-issues-voluntary-nationwide-recall-twenty-two-22-lots-blood-administration-sets) on the U.S. Food and Drug Administration (FDA) website. B. Braun notified distributors and customers on November 20, 2019; those that have affected inventory should discontinue use immediately and contact the B. Braun Medical Inc. Customer Support Department at 800-227-2862, Monday–Friday, 8 am–6 pm EST, with questions or to arrange for replacement product or refund.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program online (https://www.fda.gov/node/360543). Or for regular mail or fax, download the form (https://www.fda.gov/node/360547) or call 800-332-1088 to request a reporting form, then complete it and return to the address on the form or submit by fax to 800-FDA-0178.