Medical Device Recall: Z-0009-2021

FDA Recalls dataset · Firm: N/A · Status: Open, Classified

Recall Action Class: N/A Date Initiated: 2020-08-12 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0009-2021.

Recall Res Number
Z-0009-2021
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 Covidien Best Practices Procedure Kits containing Auto Suture Endo GIA Universal Loading Units, Parent Codes 00Z2760 - 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:  00Z2117

Related Establishments / Registrations

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