B. Braun Medical Inc: 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.

Recall number

Z-0305-2011

Recalling firm

B. Braun Medical Inc

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.

Status

Terminated

Initiated

2010-06-24

Posted

2010-11-05

Terminated

2011-10-19

Reason

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

Root 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

33,905,600 units

Distribution

Worldwide Distribution -- USA and Canada.

Lot, serial or model codes

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.

510(k) numbers

["K090905"]

PMA numbers

not on file

Product code

LHI

Firm FEI

2021236

Firm city

Irvine

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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