Medical device recalls High risk

The Anspach Effort, Inc. recalls Light Adaptor for Small Battery Drive and Small Battery Drive II.

Recall date
June 24, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2783-2016
FDA classification
Class I
Brand / firm
The Anspach Effort, Inc.
Sold / distributed
Worldwide Distribution - US Nationwide and including the countries of Canada, Austria, Australia, Belgium, Brazil, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Libya, Malay…

Why it was recalled

There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery Drive II to generate excessive internal pressure that may cause the products to burst.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Light Adaptor for Small Battery Drive and Small Battery Drive II.

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