| Class 2 Device Recall TriStaple 2.0 Curved Tip Intelligent Reload for use with Signia stapling system | |
Date Initiated by Firm | May 22, 2018 |
Date Posted | July 19, 2018 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-2516-2018 |
Recall Event ID |
80423 |
Product Classification |
Staple, implantable - Product Code GDW
|
Product | Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling system , Item Code EGIA30CTAV |
Code Information |
N7G0756KX & N7L0819KX |
Recalling Firm/ Manufacturer |
COVIDIEN MEDTRONIC 60 NIDDLETOWN AVE 2ND F NORTH HAVEN CT 06473
|
For Additional Information Contact | J. Bryan Dannettell 800-962-9888 Ext. 2 |
Manufacturer Reason for Recall | Device may be missing a sled component. The sled component is responsible for staple deployment. This
may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal
contents. |
FDA Determined Cause 2 | Process control |
Action | On May 22, 2018, all U.S. consignees received an UPDATED URGENT MEDICAL DEVICE RECALL and RETURN FORM notice via Federal Express or certified. The initial notice was sent to impacted customers on April 26, 2018.
Customers are advised to take the following required actions:
1. Immediately discontinue use, and quarantine affected products listed
2. Return affected product as indicated.
3. Complete the Recalled Product Return Form even if you do not have inventory and submit by either method below:
* Product purchased directly from Medtronic: feedback.customerservice@Covidien.com or fax to (800) 895-6140.
*Product purchased through distributor: FCAMITG@Covidien.com or fax it to (203) 492-7719. |
Distribution | Nationwide U.S.A.
Internationally to: Albania, Algeria, Austria, Belgium, Bulgaria, Croatia,
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece,
Guadeloupe, Hungary, Iceland, Ireland, Israel, Italy, Ivory Coast, Jordan,
Kazakhstan, Kuwait, Latvia, Lebanon, Luxembourg, Macedonia, Malta,
Martinique, Moldova, Morocco, Namibia, Netherlands, New Caledonia,
Norway, Pakistan, Poland, Portugal, Reunion, Romania, Russian federation,
Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden,
Switzerland, Tunisia, Turkey, United Arab Emirates & United Kingdom |
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.
|
|
|
|