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

Recall number

Z-2343-2018

Recalling firm

B. Braun Medical, Inc.

Product

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

Status

Terminated

Initiated

2018-06-04

Posted

not on file

Terminated

2020-01-13

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 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

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.

Lot, serial or model codes

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

510(k) numbers

["K151423"]

PMA numbers

not on file

Product code

NEP

Firm FEI

2523676

Firm city

Allentown

Firm state

PA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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