Recall Z-2343-2018 ยท NEP System/Device, Pharmacy Compounding
B. Braun Medical, Inc.
26-Lead Transfer Set for use with APEX Compounding System, Product Catalog Number 2112550
| Date | Jun 4, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | Urgent Medical Device Correction - Recall Notification letters were distributed on 6/4/18. The letters instruct customers to perform the following: 1. Review this Medical Device Correction Notification in its entirety and ensure that all users of the above mentioned products in your organization and other concerned persons are informed about this medical device correction - recall notification. If you are a distributor, please forward this recall notification to your customers. 2. Perform a visual inspection of valve orientation prior to installation onto APEX Compounding System in accor |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151423 | APEX Compounding System Transfer Set B.Braun Medical, Inc., Feb 19, 2016 |