Z-2343-2018Class II

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

Name: Z-2343-2018 26-Lead Transfer Set for use with APEX Compounding System, Product Catalog Number 2112550
Creator: B. Braun Medical, Inc.
Published: 2018-06-04
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2018-06-04 / Terminated

FDA source

B. Braun Medical, Inc. began a recall of 26-Lead Transfer Set for use with APEX Compounding System, Product Catalog Number 2112550 on 2018-06-04. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2343-2018
Classification: Class II
Status: Terminated
Initiated: 2018-06-04
Posted: 2018-07-03
Terminated: 2020-01-13
Recalling firm: B Braun Medical Inc
Product: 26-Lead Transfer Set for use with APEX Compounding System, Product Catalog Number 2112550
Product code: NEP System/Device, Pharmacy Compounding
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.
FDA 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 accordance with the Visual Inspection Instructions contained in Attachment 1. 3. If any misaligned valves are identified, do not use the transfer set. Please contact Customer Support at 1-800-227-2862 for product return and replacement. 4. Utilizing the attached "Medical Device Correction - Recall Notification Acknowledgement" form, please acknowledge that you have received and reviewed this information. 5. Return the completed "Medical Device Correction - Recall Notification Acknowledgement" form to B. Braun Medical Inc Quality Assurance department by faxing or e-mailing the form within two (2) weeks of receipt of this notice. It is important this form is returned to B. Braun Medical Inc can meet regulatory requirements of the United States Food and Drug Administration.
Quantity in commerce: 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.
Product codes and lots: 0061546906, 0061546910, 0061548145, 0061548146, 0061548476, 0061548477, 0061548478, 0061548479, 0061548645, 0061555100, 0061555101, 0061555102, 0061556350, 0061557521, 0061559077, 0061559628, 0061559631, 0061559852, 0061559853, 0061559854, 0061560830, 0061560831, 0061562493, 0061562494, 0061562941, 0061563541, 0061564175, 0061564176, 0061564177, 0061564179, 0061564180, 0061564431, 0061564669, 0061564670, 0061564672, 0061564673, 0061566362, 0061566363, 0061567272, 0061567809, 0061567810, 0061567811, 0061567812, 0061567813, 0061567814, 0061571324, 0061571325, 0061571326, 0061571327, 0061572464, 0061572465, 0061572466, 0061572980, 0061572981, 0061572982, 0061572983, 0061572984, 0061572985, 0061572987, 0061579647, 0061579648, 0061579651, 0061579653, 0061579654, 0061581522, 0061581585, 0061581586, 0061581590, 0061581599, 0061581602, 0061581603, 0061581982, 0061581983, 0061581984, 0061581985, 0061581986, 0061581987, 0061581988, 0061583281, 0061583282, 0061583283, 0061586220, 0061586221, 0061586222, 0061586223, 0061586224, 0061586712, 0061586713, 0061586714, 0061587151, 0061587152, 0061587153, 0061587154, 0061587155, 0061587156, 0061587157, 0061587720, 0061590070, 0061591603, 0061591618, 0061591646, 0061591660, 0061591662, 0061591663, 0061591664, 0061591665, 0061591667, 0061591675, 0061594365, 0061594366, 0061594367, 0061594368, 0061594369, 0061599040, 0061599159, 0061599160, 0061599161, 0061599162, 0061599163, 0061599164, 0061599165, 0061603919, 0061603920, 0061603921, 0061608039, 0061614625, 0061614626, 00VL559752

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2343-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2343-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-11	2018-07-03

Product code NEP

K151423Class IIAPEX Compounding System Transfer SetB.Braun Medical, Inc. / cleared 2016-02-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)