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U.S. Department of Health and Human Services

Class 2 Device Recall Part : SAM XTC, Model: HiViz Orange or Civilian

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 Class 2 Device Recall Part : SAM XTC, Model: HiViz Orange or Civiliansee related information
Date Initiated by FirmMay 02, 2018
Create DateJune 14, 2018
Recall Status1 Terminated 3 on July 01, 2020
Recall NumberZ-2227-2018
Recall Event ID 80140
Product Classification Tourniquet, nonpneumatic - Product Code GAX
ProductPart #: SAM XT-C, Model: Hi-Viz Orange or Civilian
Code Information Lot #: XT1711, XT1712, XT1715, XT1716, XT1717, XT1719, XT1722, XT1723, XT1724, XT1726, XT1730, XT1731, XT1732, XT1734, XT1735, XT1736, XT1737, XT1738, XT1741, XT1744, XT1745, XT1748, XT1750, XT1751, XT1803, XT1804, XT1806, XT1807, XT1808
Recalling Firm/
Manufacturer		 The Seaberg Company Inc
27350 SW 95th Ave Ste 3038
Wilsonville OR 97070-7709
For Additional Information ContactJamie Burdett
800-580-3519
Manufacturer 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.
FDA Determined
Cause 2		Employee error
ActionOn 05/02/2018, the firm posted a press release notifying customers of a recall of all unused SAM XT Extremity Tourniquets (SAM XT) due to a possible failure of the stitches securing the buckle to the nylon belt that could pose a potential risk when used on a human patient to stop arterial blood flow. On 05/03/2018, recall notification forms were mailed to customers via overnight mail service.
DistributionUSA: 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, Thailand, UAE
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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