—#44161

Product

B. Braun Hyperformer EVA Mixing Container with Hyperformer Compatible Connector, 4000ml size, Catalog Number SH4000, Batch Numbers 05A14474, 05A18561, and 05A19926

FDA product code: KPE — Container, I.V.
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: Lot Numbers: 05A14474, 05A18561, & 05A19926

Why it was recalled

B. Braun Medical has been notified by the manufacturer of the product (Stedim) that a small percentage of the lots leak from the set port when the set port is opened. The leak was identified by Stedim to be due to the incorrect placement of a septum in the set port. The set closure is intact and the leak remains internal until the set port is opened.

Root cause (FDA determination)

Other

Action the firm took

A recall notification letter was sent to the 22 customers who received the product between 12/1/05 and 1/11/06. The recall packages included a letter addressed to either the Director of Pharmacy/Director of Nursing, Materials Manager, or Distributor, as appropriate. They were mailed via US Post Office certified return receipt mail. Customers were instructed by letter to return all product at their facility to B. Braun Medical, Inc. in Breinigsville Pennsylvania. A Recall Information Form and a postage paid B. Braun Medical, Inc. return envelope were included in the recall package for the customer''s use.

Recalling firm

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

Distribution

Distribution pattern: Nationwide to: CA, CT, FL, GA, KS, MD, MI, NC, NJ, NY, SC, TN, & TX

Timeline

Recall initiated: 2006-02-06
Posted by FDA: 2006-03-03
Terminated: 2008-05-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #44161. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.