Recalls / —

—#51960

Product

B.Braun HyperFormer Pump Dispensing Set, Catalog Number V9900-02. The product is shipped in cases containing 10 sets.

FDA product code

LHI — Set, I.V. Fluid Transfer

Device class

Class 2

Medical specialty

General Hospital

510(k) numbers

K905201

Affected lot / code info

Lot number 0060911602

Why it was recalled

The integrity of the sterile product barrier may be compromised

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm

B. Braun Medical, Inc.

Address

901 Marcon Boulevard, Allentown, Pennsylvania 18109-9512

Distribution

Distribution pattern

Nationwide distribution --- including states of GA, MA, OH, and TX

Timeline

Recall initiated

2007-04-11

Posted by FDA

2007-05-05

Terminated

2007-08-07

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #51960. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.