PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: July 11, 2018 Initiated: June 4, 2018 #Z-2343-2018

Product Description

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

Reason for Recall

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.

Details

Recalling Firm
B. Braun Medical, Inc.
Units Affected
12320
Distribution
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.
Location
Allentown, PA

Frequently Asked Questions

What product was recalled?
26-Lead Transfer Set for use with APEX¿ Compounding System, Product Catalog Number 2112550. Recalled by B. Braun Medical, Inc.. Units affected: 12320.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 11, 2018. Severity: Moderate. Recall number: Z-2343-2018.