| Date Initiated by Firm |
August 12, 2020 |
| Create Date |
October 01, 2020 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-0005-2021 |
| Recall Event ID |
86214 |
| 510(K)Number |
K111825
|
| Product Classification |
Staple, implantable - Product Code GDW
|
| Product |
Endo GIA Auto Suture Universal Loading Unit 45 mm - 2.5mm, Item Code 030454 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. |
| Code Information |
Lot Numbers: T0A018X T8B045X T8E051X T8L052X T9E050X T0A106X T8B046X T8E052X T8L101X T9F024X T0B131X T8B047X T8E065X T8L131X T9F037X T0D138X T8C025X T8E066X T8L132X T9F040X T0E011X T8C030X T8H015X T8L143X T9F044X T7G001X T8C031X T8H016X T8M080X T9F045X T7H004X T8C043X T8H017X T8M092X T9F046X T7H007X T8D001X T8H018X T8M093X T9F097X T7J025X T8D002X T8H049X T8M094X T9G031X T7K018X T8D003X T8J012X T9A006X T9G124X T7K034X T8D004X T8J026X T9A034X T9G125X T7L022X T8D005X T8J039X T9A035X T9H041X T7L036X T8D006X T8J040X T9A118X T9H102X T7L037X T8D014X T8K006X T9B060X T9H110X T8A058X T8D015X T8K008X T9C023X T9J071X T8A059X T8D047X T8L012X T9C024X T9J114X T8A062X T8D048X T8L013X T9C058X T9K077X T8A063X T8D049X T8L014X T9C059X T9L021X T8A064X T8D050X T8L015X T9D053X T9L037X T8A065X T8D051X T8L016X T9D099X T9M017X T8B001X T8D052X T8L049X T9D124X T9M018X T8B002X T8D053X T8L050X T9D125X T9C060X T8B044X T8D054X |
Recalling Firm/
Manufacturer |
Covidien, LP
60 Middletown Ave
North Haven CT 06473-3908
|
Manufacturer 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.
|
FDA Determined
Cause 2 |
Under Investigation by firm |
| Action |
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. |
| Quantity in Commerce |
900,007 total |
| Distribution |
Worldwide distribution - US Nationwide and Global Distribution. |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
| 510(K) Database |
510(K)s with Product Code = GDW and Original Applicant = COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H
|
