Product Wiki · Recalls · U.S. FDA — Device Enforcement

Covidien Duet TRS 60 3.5 mm Universal Straight Single Use Loading Unit Product Code: DUET6035. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, trans — recall Z-2436-2012

U.S. FDA — Device Enforcement · United States · 2012-08-21 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2436-2012
Date of alert: 2012-08-21
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Covidien LP
Product category: device
Product type: Devices

Reported risk: Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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