—#164915

Product

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

FDA product code: NEP — System/Device, Pharmacy Compounding
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K151423
Affected lot / code info: 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

Why it was 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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: B. Braun Medical, Inc.
Address: 901 Marcon Blvd, Allentown, Pennsylvania 18109-9512

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2018-06-04
Terminated: 2020-01-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #164915. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.