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U.S. Department of Health and Human Services

Class 2 Device Recall 26Lead Transfer Set for use with APEX Compounding System

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  Class 2 Device Recall 26Lead Transfer Set for use with APEX Compounding System see related information
Date Initiated by Firm June 04, 2018
Create Date July 03, 2018
Recall Status1 Terminated 3 on January 13, 2020
Recall Number Z-2343-2018
Recall Event ID 80231
510(K)Number K151423  
Product Classification System/device, pharmacy compounding - Product Code NEP
Product 26-Lead Transfer Set for use with APEX¿ Compounding System, Product Catalog Number 2112550
Code Information 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
Recalling Firm/
Manufacturer		 B. Braun Medical, Inc.
901 Marcon Blvd
Allentown PA 18109-9512
For Additional Information Contact 1-800-227-2862
800-227-2862
Manufacturer 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 Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NEP and Original Applicant = B. BRAUN MEDICAL INC.
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