Wilsonville, OR, United States
The Seaberg Company Inc recalls
1 recall recorded since 2018, most recently on 2 May 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 2 May 2018
- Terminated
- 1 July 2020
- 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.
- Distribution
- USA: CA, MD, OH, FL, ID, CO, CT, OR, AZ, IL, ME, MO, NY, SC, MI, AR, MT, CT, WA, TX, KY, NC, NJ, PA OUS: Australia, Canada, China, Columbia, Costa Rica, Europe (EU), Hong Kong, Iceland, India, Iraq, Israel, Japan, Kenya, Korea, Lebanon, Malaysia, Russia, Saudi Arabia, Singapore, South Africa, Tha
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2226-2018, Z-2228-2018, Z-2227-2018
- Part #: SAM XT-M, Model: Tactical Black or Military
- Part #: SAM XT-C, Model: Hi-Viz Blue
- Part #: SAM XT-C, Model: Hi-Viz Orange or Civilian
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.