—#179451

Product

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

FDA product code: GDW — Staple, Implantable
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K111825
Affected lot / code info: Lot Number: P9E0022Y

Why it was recalled

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

Root cause (FDA determination)

Package design/selection

Action the firm took

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: rs.assurancequality@medtronic.com.

Recalling firm

Firm: COVIDIEN LLC
Address: 15 Hampshire St, Mansfield, Massachusetts 02048-1113

Distribution

Distribution pattern: US Nationwide, Israel, and Japan

Timeline

Recall initiated: 2020-01-17
Terminated: 2022-07-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #179451. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.