—#118621

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.

FDA product code: LHI — Set, I.V. Fluid Transfer
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K090905, K900865, K904855
Affected lot / code info: Material BC1300, Lot number 61286479.

Why it was recalled

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

Root cause (FDA determination)

Equipment maintenance

Action the firm took

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.

Recalling firm

Firm: B. Braun Medical, Inc.
Address: 901 Marcon Boulevard, Allentown, Pennsylvania 18109-9512

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2013-04-04
Posted by FDA: 2013-11-27
Terminated: 2014-08-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #118621. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.