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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm March 04, 2021
Create Date April 09, 2021
Recall Status1 Completed
Recall Number Z-1385-2021
Recall Event ID 87475
510(K)Number K191070  
Product Classification Diacetyl-monoxime, urea nitrogen - Product Code CDW
Product Covidien Signia Small Diameter Curved Tip Intelligent Reload
30 mm Vascular/Thin 8 mm - Short

Item Code:SIGSDS30CTVT
Code Information Lot Numbers: N0A0274UY N0D0037UY N0G0491UY N0K1016UY N0A0897UY N0D0391UY N0G0736UY N0L0077UY N0B0640UY N0E0175UY N0J0510UY N0M0063UY N0B0937UY N0E0802UY N0J0680UY N0M0259UY N0C0144UY N0F1055UY N0J0999UY N9K1094UY N0C0486UY N0G0185UY N0K0584UY N9L0795UY N0C1115UY N0G0250UY N0K0805UY  UDI: 10884521741874 20884521741871
Recalling Firm/
Manufacturer		 Covidien, LP
60 Middletown Ave
North Haven CT 06473-3908
For Additional Information Contact SAME
203-492-5000
Manufacturer Reason
for Recall		 Potential for the device safety interlock to fail. The safety interlock prevents an empty single-use reload from being erroneously fired a second time. If the safety interlock fails and the empty single-use reload is fired a second time, the stapler may cut tissue but no staples will deploy from the empty reload, potentially resulting in a failed anastomosis, bleeding, tissue trauma, and the potential need to convert to an open procedure.
FDA Determined
Cause 2		 Under Investigation by firm
Action Covidien/Medtronic issued Urgent Medical Device Recall via Federal Express and/or certified mail beginning March 4, 2021, states reason for recall, health risk and action to take: 1. Please immediately quarantine and discontinue use of affected item codes with associated lot numbers listed on 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 Signia" small diameter curved tip intelligent reload 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. 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 15298 units WW: 9204 US; 6094 OUS
Distribution Worldwide distribution - US Nationwide distribution and the countries of Austria, Belgium, Chile, China, Denmark, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, 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.
510(K) Database 510(K)s with Product Code = CDW and Original Applicant = Covidien
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