Recall Z-2343-2018— B. Braun Medical, Inc.

Name: FDA recall Z-2343-2018
Creator: U.S. Food and Drug Administration
Published: 2018-06-04

Class II · Terminated

Class II FDA medical device recall by B. Braun Medical, Inc., initiated 2018-06-04, terminated 2020-01-13. It names one FDA 510(k) clearance: K151423. Product: 26-Lead Transfer Set for use with APEX¿ Compounding System, Product Catalog Number 2112550. Reason: 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..

Recalling firm: B. Braun Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-06-04
Terminated: 2020-01-13
Firm location: Allentown, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K151423 — APEX Compounding System Transfer SetB.Braun Medical, Inc.·cleared 2016-02-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.