FDA Device Recall Z-0004-2021: Recall Record

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0004-2021.

Recall Res Number

Z-0004-2021

Recalling Firm / Manufacturer

N/A

FEI Number

1219930

Recall Status

Open, Classified

Recall Classification

N/A

Date Initiated

2020-08-12

Date Posted

N/A

Date Terminated

N/A

Product Code

GDW

Event Number

86214

Product Quantity

900,007 total

Product Description Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

Reason for Recall The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.

Action Details Urgent Medical Device Recall notification letters dated 8/12/20 were sent to customers. Required Actions: 1.Please immediately quarantine and discontinue use of affected item codes with associated lot numbers listedon Attachment A. 2.Please return affected product as indicated below. All unused products from the affected item codes and associated lot numbers must be returned. 3.If you have distributed the Covidien Endo GIA" Auto Suture" universal articulating loading units listed on Attachment A, please promptly forward the information from this letter to those recipients. 4.Complete the Recalled Product Return Form even if you do not have inventory. We regret any inconvenience this may cause. We are committed to patient safety and appreciate your prompt attention to this matter. If you have any questions regarding this communication, please contact your Medtronic representative or Customer Service at 800-962-9888, option 2.

Distribution Pattern Worldwide distribution - US Nationwide and Global Distribution.

Code Information / Serial Numbers Lot Numbers: T7F017X T7J023X T7L032X T7L034X T8L100X T7F025X T7J024X T7L033X T7L035X T9F138X T7F026X T7K020X

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Medical Device Recall: Z-0004-2021

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer