Z-0783-2007

B.Braun HyperFormer Pump Dispensing Set, Catalog Number V9900-02. The product is shipped in cases containing...

Name: Z-0783-2007 B.Braun HyperFormer Pump Dispensing Set, Catalog Number V9900-02. The product is shipped in cases containing...
Creator: B. Braun Medical, Inc.
Published: 2007-04-11
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2007-04-11 / Terminated / root cause: sterility

FDA source

B. Braun Medical, Inc. began a recall of B.Braun HyperFormer Pump Dispensing Set, Catalog Number V9900-02. The product is shipped in cases containing 10 sets on 2007-04-11. The reason FDA records is "The integrity of the sterile product barrier may be compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0783-2007
Status: Terminated
Initiated: 2007-04-11
Posted: 2007-05-05
Terminated: 2007-08-07
Recalling firm: B Braun Medical Inc
Product: B.Braun HyperFormer Pump Dispensing Set, Catalog Number V9900-02. The product is shipped in cases containing 10 sets.
Product code: LHI Set, I.V. Fluid Transfer
Reason for recall: The integrity of the sterile product barrier may be compromised
Root cause tag: sterility
FDA root cause: Other
Action: An Urgent Product Removal Notice was issued to the distributors on 4/11/07. The notice informs the distributors of the problem, the need to conduct a sub recall and to return the product.
Quantity in commerce: 180 units
Distribution: Nationwide distribution --- including states of GA, MA, OH, and TX
Product codes and lots: Lot number 0060911602

Product code LHI

K905201Class IITpn Fluid Transfer SetMcgaw, Inc. / cleared 1991-01-02

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)