FDA-Device2017-01-04Class II
Arthex S3 Arm Sleeve Connector; Catalog Number AR-1650-02; manufactured and distributed between March and November 2016.
Allen Medical Systems, Inc.
Hazard
During use, the unit could separate un-expectantly. This failure would allow the patient's arm to fall out of suspension during a procedure, possibly causing moderate injury to the patient. This potential defect is not apparent to the user.
Sold states
US Distribution to the state of : FL
Affected count
420 devices
Manufactured in
One Post Office Square, N/A, Acton, MA, United States
Products
Arthex S3 Arm Sleeve Connector; Catalog Number AR-1650-02; manufactured and distributed between March and November 2016.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0928-2017Don't want to check this manually?
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