—#92785

Product

B. Braun addEASE Binary Connector, Catalogue #N7990, 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.

FDA product code: LHI — Set, I.V. Fluid Transfer
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K090905
Affected lot / code info: Lot Numbers: 60888981, 60896155, 60896156, 60896157, 60896158, 60896159, 60896160, 60896161, 60896162, 60909722, 60909724, 60909725, 60909726, 60909728, 60909729, 60929782, 60929788, 60930263, 60930264, 60930265, 60930266, 60930267, 60930268, 60930269, 60930270, 60930271, 60930272, 60930273, 60930274, 60930275, 60930276, 60930277, 60930278, 60930279, 60939498, 60939499, 60939500, 60939501, 60939502, 60939503, 60950897, 60950898, 60968943, 60972166, 60972167, 60972168, 60972170, 60972171, 60972172, 60972177, 60972178, 60972179, 60972181, 60972182, 60984561, 60984562, 60984564, 60984656, 60984820, 60987936, 60987937, 60987939, 60988419, 60990712, 60992400, 60993569, 60993570, 60993571, 60993572, 60993573, 60993574, 60994657, 60994658, 60996549, 60996550, 60996890, 60996891, 60996893, 60996894, 60996895, 60997997, 60997998, 60997999, 60998000, 61001335, 61001972, 61001973, 61001974, 61001975, 61001976, 61009984, 61009986, 61014184, 61014185, 61014186, 61014187, 61014573, 61016597, 61019646, 61019647, 61019648, 61019649, 61019650, 61022786, 61022787, 61022788, 61022790, 61022791, 61022792, 61025398, 61025399, 61025399, 61027190, 61027191, 61027192, 61027193, 61027194, 61028564, 61028567, 61029635, 61029636, 61031170, 61031171, 61031172, 61031173, 61031175, 61031177, 61034921, 61034922, 61034923, 61034925, 61034926, 61034927, 61037565, 61037566, 61037567, 61037569, 61037570, 61037571, 61037572, 61037573, 61043243, 61043244, 61044023, 61044024, 61044025, 61044778, 61044779, 61044780, 61044781, 61044782, 61044783, 61044784, 61047315, 61047316, 61047317, 61047319, 61047320, 61047321, 61050209, 61050210, 61050211, 61050212, 61050214, 61050215, 61050216, 61050217, 61050218, 61050219, 61050220, 61050221, 61050222, 61050223, 61050224, 61054305, 61054306, 61054307, 61054308, 61054309, 61054310, 61054312, 61054313, 61062242, 61062243, 61062244, 61062246, 61062247, 61062250, 61062254, 61062255, 61062256, 61062258, 61074453, 61074454, 61074455, 61074457, 61074460, 61074461, 61074462, 61074464, 61074465, 61079565, 61079567, 61079568, 61079570, 61079571, 61079572, 61079573, 61079574, 61079575, 61079576, 61079577, 61079578, 61083695, 61083700, 61083703, 61083705, 61083706, 61083707, 61083708, 61083709, 61089235, 61089236, 61089237, 61089238, 61089239, 61089242, 61089243, 61089244, 61092272, 61092273, 61093525, 61093526, 61093527, 61093528, 61093529, 61093530, 61093531, 61093532, 61093533, 61093534, 61093535, 61095666, 61095667, 61095668, 61095669, 61095670, 61095671, 61095672, 61095673, 61101776, 61101777, 61101779, 61101780, 61101781, 61103766, 61103767, 61103768, 61103769, 61103770, 61103771, 61103773, 61103774, 00VL026815, 00VL026817, 00VL026818, 00VL053187, 00VL053188, 00VL053189, 00VL888968, 00VL888969, and 00VL888980.

Why it was recalled

During this insertion, fragmentation of the PAB container stopper may occur resulting in a small amount of visible particulates in the solution.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: B. Braun Medical Inc
Address: 2525 McGaw Ave, Irvine, California 92614-5841

Distribution

Distribution pattern: Worldwide Distribution -- USA and Canada.

Timeline

Recall initiated: 2010-06-24
Posted by FDA: 2010-11-05
Terminated: 2011-10-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #92785. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.