Reported Jan 4, 2017 · Terminated
Arthex S3 Arm Sleeve Connector; Catalog Number AR-1650-02; manufactured and distributed between March and November 2016.
Allen Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Allen Medical Systems, Inc. · One Post Office Square · Acton, MA · 01720
Is this the product you have?
- Arthex S3 Arm Sleeve Connector; Catalog Number AR-1650-02; manufactured and distributed between March and November 2016.
- Lot codes and dates
387 of 387 codes
499633499694499274499367499410499383499479499573499615499634499695499275499368499411499384499480499574499616499635499696499276499369499412499385499481499575499617499636499697499277499370499413499386499482499576499618499637499698499278499371499414499387499483499577499619499638499699499279499372499415499388499484499578499620499639499700499280499323499416499389
- Amount recalled
- 420 devices
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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