B. Braun Medical, Inc. recalls 26-Lead Transfer Set for use with APEX¿ Compounding System, Product Catalog Number 2112550

Recall date

June 4, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2343-2018

FDA classification

Class II

Brand / firm

B. Braun Medical, Inc.

Sold / distributed

The products were distributed to the following US states: AL, CA, CO, CT, FL, GA, IL, LA, MA, MD, MI, MN, MO, NC, NJ, NV, OH, PA, TX, and WA.

Why it was recalled

There is a potential for valves on the 26-Lead Transfer Set to be incorrectly oriented. When a transfer set with an incorrectly oriented valve is installed on the system, there is potential for unintended admixture.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

26-Lead Transfer Set for use with APEX¿ Compounding System, Product Catalog Number 2112550