Home / Recalls / Medical Devices
Allen Medical Systems, Inc. recalls Arthex S3 Arm Sleeve Connector; Catalog Number AR-1650-02; manufactured and distributed between March and November 2016.
Recalled January 4, 2017 · FDA recall Z-0928-2017 · Allen Medical Systems
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. · FDA Class II
Units
420 devices
Sold at
US Distribution to the state of : FL
Description
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.
Product
Arthex S3 Arm Sleeve Connector; Catalog Number AR-1650-02; manufactured and distributed between March and November 2016.
Manufacturer(s)
Allen Medical Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →