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U.S. Department of Health and Human Services

Class 2 Device Recall Endo GIA 60 mm Articulating Vascular/Medium Loading Unit with TriStaple

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 Class 2 Device Recall Endo GIA 60 mm Articulating Vascular/Medium Loading Unit with TriStaplesee related information
Date Initiated by FirmMay 22, 2018
Date PostedJuly 19, 2018
Recall Status1 Open3, Classified
Recall NumberZ-2506-2018
Recall Event ID 80423
Product Classification Staple, implantable - Product Code GDW
ProductEndo GIA 60 mm Articulating Vascular/Medium Loading Unit with Tri-Staple Technology, Item Code EGIA60AVM
Code Information N7M0045KX, N7M0398KX, N8A0523KX, N8B0088KX, N7M0070KX, N8A0255KX & N8B0080KX
Recalling Firm/
Manufacturer
COVIDIEN MEDTRONIC
60 NIDDLETOWN AVE 2ND F
NORTH HAVEN CT 06473
For Additional Information ContactJ. 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
ActionOn 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.
DistributionNationwide 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 CycleTPLC 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.
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