FDA-Device2014-07-02Class II
ANSPACH***REF SP-3014-00***4mm Fluted Ball for MRI***Rx Only*** This device is intended to be used with Anspach Systems
The Anspach Effort, Inc.
Hazard
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
Sold states
Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .
Affected count
130
Manufactured in
4500 Riverside Drive, N/A, Palm Beach Gardens, FL, United States
Products
ANSPACH***REF SP-3014-00***4mm Fluted Ball for MRI***Rx Only*** This device is intended to be used with Anspach Systems
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1907-2014Don't want to check this manually?
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