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U.S. Department of Health and Human Services

Class 2 Device Recall B. Braun 13mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC2000

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  Class 2 Device Recall B. Braun 13mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC2000 see related information
Date Initiated by Firm April 04, 2013
Date Posted November 27, 2013
Recall Status1 Terminated 3 on August 26, 2014
Recall Number Z-0425-2014
Recall Event ID 65356
510(K)Number K090905  K900865  K904855  
Product Classification Set, i.V. Fluid transfer - Product Code LHI
Product 13mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC1300

Product is intended for fluid transfer between a Partial Additive Bag (PAB(R)) container and a drug vial.
Code Information Material BC1300, Lot number 61286479.
Recalling Firm/
Manufacturer		 B. Braun Medical, Inc.
901 Marcon Boulevard
Allentown PA 18109-9512
For Additional Information Contact Customer Support
800-227-2862
Manufacturer Reason
for Recall		 Possible solution leakage at the interface of the addEASE(TM) Binary Connector (Product Codes BC2000 and BC1300) and the PAB(R) bag. Based on extensive root cause investigation, it has been determined that the leakage is the result of a misaligned cannula (needle) on the addEASE(TM) Binary Connector, which pierces the PAB(R) bag stopper to access the solution. The misaligned cannula may result i
FDA Determined
Cause 2		 Equipment maintenance
Action B Braun sent an Urgent - Medical Device Removal Notification letter dated April 4, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by he customer. Customers were instructed to review the Product Recall Notification in its entirety and ensure that all users in their organization are informed about this voluntary product recall. Determine their current inventory of the affected lots within their distribution center. Contact their customers that have received the affected lots and inform them of this voluntary product recall. Combine both their inventory, and the inventory reported by their customers, and utilize their specific "Product Removal Acknowledgement" form to record the total number of individual units (within partial cases) and the number of full-unopened cases. If no inventory remaining enter zero (0). Return the completed Acknowledgement Form to BBMI Quality Assurance in the self addressed envelope or fax to 610-849-1197. Customers should call Customer Support Department at 800-227-2862 to arrange for eturn and replacement product or for questions. For questions regarding this recall call 800-227-2862.
Quantity in Commerce 4,000 units
Distribution Nationwide Distribution
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 = LHI and Original Applicant = B. BRAUN MEDICAL, INC.
510(K)s with Product Code = LHI and Original Applicant = KENDALL MCGAW LABORATORIES, INC.
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