Recall Z-0928-2017— Allen Medical Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by Allen Medical Systems, Inc., initiated 2016-11-23, terminated 2019-08-20. FDA's recall record names no specific 510(k) clearance for this event. Product: Arthex S3 Arm Sleeve Connector; Catalog Number AR-1650-02; manufactured and distributed between March and November 2016.. Reason: 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..
- Recalling firm
- Allen Medical Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-11-23
- Terminated
- 2019-08-20
- Firm location
- Acton, MA, United States
Product description
Arthex S3 Arm Sleeve Connector; Catalog Number AR-1650-02; manufactured and distributed between March and November 2016.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.