Medical device recalls Moderate risk

B. Braun Medical, Inc. recalls Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start procedures

Recall date
July 29, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0691-2017
FDA classification
Class II
Brand / firm
B. Braun Medical, Inc.
Sold / distributed
Nationwide Distribution to GA, IL, and FL

Why it was recalled

Positive results from non-routine sterility testing commissioned by B. Braun Medical Inc. (BBMI) for the finished product of this lot.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start procedures

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