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Terminated

Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery Item Code: EGIAUSTND

FDA Recall Z-1264-2020 · Posted None

Recalling FirmCOVIDIEN LLC
Recall StatusTerminated
Product CodeGDW
Date Initiated2020-01-17
Date Terminated2022-07-29
Product Quantity2,180 units

Reason for Recall

Potential for the sterile barrier to be compromised. Products with a compromised sterile barrier may result in a potentially increased risk for infection

Firm Action

Medtronic notified consignees by letter via Federal Express and/or certified mail beginning January 17, 2020. The letter informs of the reason for recall, health risk and action to take: Immediately quarantine and discontinue use of the affected itemcode and lot; " Return affected product; Forward the information to anyone who they have distributed. Complete the Recalled Product Return Form even if you do not have inventory. Questions: Email Medtronic Post Market Vigilance at: [email protected].

Root Cause

Package design/selection

Distribution Pattern

US Nationwide, Israel, and Japan

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K111825ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERSCovidien, Formerly US Surgical A Divison of Tyco H · 2011-10-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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