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Terminated

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

FDA Recall Z-0783-2007 · Posted 2007-05-05

Recalling FirmB. Braun Medical, Inc.
Recall StatusTerminated
Product CodeLHI
Date Initiated2007-04-11
Date Terminated2007-08-07
Product Quantity180 units

Reason for Recall

The integrity of the sterile product barrier may be compromised

Firm 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.

Root Cause

Other

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K905201TPN FLUID TRANSFER SETMcgaw, Inc. · 1991-01-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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