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U.S. Department of Health and Human Services

Class 2 Device Recall B. Braun Hyperformer EVA Mixing Container with Hyperformer Compatible Connector

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  Class 2 Device Recall B. Braun Hyperformer EVA Mixing Container with Hyperformer Compatible Connector see related information
Date Initiated by Firm February 06, 2006
Date Posted March 03, 2006
Recall Status1 Terminated 3 on May 28, 2008
Recall Number Z-0586-06
Recall Event ID 34598
Product Classification Container, I.V. - Product Code KPE
Product B. Braun Hyperformer EVA Mixing Container with Hyperformer Compatible Connector, 4000ml size, Catalog Number SH4000, Batch Numbers 05A14474, 05A18561, and 05A19926
Code Information Lot Numbers: 05A14474, 05A18561, & 05A19926
Recalling Firm/
Manufacturer		 B. Braun Medical Inc
2525 McGaw Ave
Irvine CA 92614-5841
For Additional Information Contact Wendy Ricapito
949-660-2678
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Other
Action 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.
Quantity in Commerce 13,480
Distribution Nationwide to: CA, CT, FL, GA, KS, MD, MI, NC, NJ, NY, SC, TN, & TX
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.
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