Z-0586-06

B. Braun Hyperformer EVA Mixing Container with Hyperformer Compatible Connector, 4000ml size, Catalog Number...

Name: Z-0586-06 B. Braun Hyperformer EVA Mixing Container with Hyperformer Compatible Connector, 4000ml size, Catalog Number...
Creator: B. Braun Medical Inc
Published: 2006-02-06
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2006-02-06 / Terminated / root cause: manufacturing process

FDA source

B. Braun Medical Inc began a recall of B. Braun Hyperformer EVA Mixing Container with Hyperformer Compatible Connector, 4000ml size, Catalog Number SH4000, Batch Numbers 05A14474, 05A18561, and... on 2006-02-06. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0586-06
Status: Terminated
Initiated: 2006-02-06
Posted: 2006-03-03
Terminated: 2008-05-28
Recalling firm: B Braun Medical Inc
Product: B. Braun Hyperformer EVA Mixing Container with Hyperformer Compatible Connector, 4000ml size, Catalog Number SH4000, Batch Numbers 05A14474, 05A18561, and 05A19926
Product code: KPE Container, I.V.
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.
Root cause tag: manufacturing process
FDA root cause: 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
Product codes and lots: Lot Numbers: 05A14474, 05A18561, & 05A19926

Product code KPE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)