Class 1 Device Recall B. Braun addEASE Binary Connector

• Date Initiated by Firm: June 24, 2010
• Date Posted: November 05, 2010
• Recall Status: Terminated on October 19, 2011
• Recall Number: Z-0306-2011
• Recall Event ID: 56164
• 510(K)Number: K090905
• Product Classification: I.V. Fluid Transfer Set - Product Code LHI
• Product: B. Braun addEASE Binary Connector, Catalogue #N7993, 200 units (50 units per bag with 4 bags per shipping box) ; ; Intended for use in a pharmacy setting to connect a B. Braun 250mL Excel IV solution bag to a 20 mm drug vial for reconstituting or mixing the drug in the vial with the solution in the bag.
• Code Information: Lot Numbers: 60928513, 60936541, 60936543, 60942059, 60950900, 60953588, 60969534, 60972173, 60973280, 60983742, 60997643, 61003958, 61017469, 61027183, 61027186, 61031167, 61031168, 61042196, 61045157, 61056656, 61057867, 61058745, 61073202, 61078826, 61085625, 61096650, 61102775, 00VL907673, 00VL907677, 00VL912573, 00VL927133, 00VL927134, and 00VL927135.
• Recalling Firm/ Manufacturer: B. Braun Medical Inc; 2525 McGaw Ave; Irvine CA 92614-5841
• For Additional Information Contact: Bob Mitchell; 949-660-2730
• Manufacturer Reason for Recall: During this insertion, fragmentation of the PAB container stopper may occur resulting in a small amount of visible particulates in the solution.
• FDA Determined Cause: Device Design
• Action: On July 8, 2010 B Braun sent an Urgent - Medical Device Recall letter, dated June 28, 2010, to consignees informing them of the recall and that further distribution or use of the affected product should cease immediately. The attached "Product Removal Acknowledgement" form should be used to record the number of units and full-unopened cases that customers have in their inventory. The completed form should be returned via mail or fax within 2 weeks of receipt. If consignees have any full or partial cases of these affected products, they are to please call the Customer Support Department at (800) 227-2862 to arrange for return. Canadian customers may call (800) 624-2920. International customers may call (610) 691-5400. A Customer Support Representative will provide consignees with instructions for handling the affected product. The firm will arrange for unopened cases to be returned to B. Braun Medical, Inc. for proper disposal. Individual units (out of shipping cases) may be destroyed at the consignees facility. Consignees were informed that B. Braun is currently working to resolve this issue and provide an acceptable alternative to the market. They expect this product to be available in August 2010. In the interim, B. Braun PAB containers can continue to be used safely with a standard syringe and needle in accordance with the Direction for Use. If customers have additional questions regarding with a matter, they are to call B. Braun Customer Support Department at the number listed above. Should consignees identify product where this condition has occurred, consignees were asked to report it promptly to B. Braun Medical Inc. by contacting the B. Braun Clinical and Technical support at 1-800-854-6851.
• Quantity in Commerce: 2,500,000 units
• Distribution: Worldwide Distribution -- USA and Canada.
• 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.