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Covidien, LP Recall 94128

Description: Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT

Covidien, LP Recall 94128 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1457-2024
Event ID94128
Event DescriptionSignia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
Product TypeDevices
DistributionWorldwide distribution - US Nationwide and the countries of France, Hong Kong, Israel and Japan.
Quantity30 Units
Recall ReasonUnder certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The issue is related to components in impacted reloads that are not fully secure, which leads to uncontrolled articulation. The issue can occur using either the Endo GIA" Ultra Universal Stapler or Signia" Stapling System.
Device Classification20240410
Device Code InfoModel Number: SIGSDS30CTVT; UDI/DI: 10884521741881; Lot number: N3L1909UY;
Center Classification Date20240401
Recall Initiation Date20240214
Recalling FirmCovidien, LP
Initial Notification Letter
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