Recall Z-2226-2018— The Seaberg Company Inc
Class II · Terminated
Class II FDA medical device recall by The Seaberg Company Inc, initiated 2018-05-02, terminated 2020-07-01. FDA's recall record names no specific 510(k) clearance for this event. Product: Part #: SAM XT-M, Model: Tactical Black or Military. Reason: Based on internal testing, results indicated a possible failure of the stitches securing the buckle to the nylon belt could occur, posing a potential risk when used on a human patient to stop arterial blood flow. There is a remote chance that a serious injury and/or death could occur as a result of the failure of the device..
- Recalling firm
- The Seaberg Company Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-05-02
- Terminated
- 2020-07-01
- Firm location
- Wilsonville, OR, United States
Product description
Part #: SAM XT-M, Model: Tactical Black or Military
Reason for recall
Based on internal testing, results indicated a possible failure of the stitches securing the buckle to the nylon belt could occur, posing a potential risk when used on a human patient to stop arterial blood flow. There is a remote chance that a serious injury and/or death could occur as a result of the failure of the device.
Data sourced from openFDA. This site is unofficial and independent of the FDA.