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U.S. Department of Health and Human Services

Class 2 Device Recall Endo GIA Articulating Reloads with TriStaple Technology

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  Class 2 Device Recall Endo GIA Articulating Reloads with TriStaple Technology see related information
Date Initiated by Firm May 17, 2019
Create Date June 16, 2019
Recall Status1 Open3, Classified
Recall Number Z-1826-2019
Recall Event ID 82950
510(K)Number K111825  K160176  
Product Classification Staple, implantable - Product Code GDW
Product EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT
Code Information lots N4D0328KX N4D0338KX N4E0796KX N4E0846KX N4E0980KX N4E1018KX N4E1059KX N4E1173KX N4E1269KX N4E1654KX N4E1655KX N4G0523KX N4G1541KX N4H0078KX N4J0215KX N4J0250KX N4J0271KX N4J1002KX N4J1217KX N4J1247KX N4K1465KX N4M0921KX N5B0285KX N5B0340KX N5B0417KX N5B0484KX N5B0680KX N5D0467KX N5D0497KX N5D0550KX N5D0609KX N5D0660KX N5D0736KX N5D0765KX N5D1008KX N5E0068KX N5E0143KX N5E0297KX N5E0727KX N5E0756KX N5F0096KX N5F1223KX N5F1382KX N5G0244KX N5G0329KX N5G0339KX N5G0355KX N5G0405KX N5G0414KX N5G0809KX N5G0868KX N5J1153KX N5J1201KX N5J1233KX N5K0045KX N5K0089KX N5K0115KX N5M0172KX N5M0662KX N5M0693KX N5M0732KX N5M0741KX N6A0913KX N6B0332KX N6C0462KX N6D0388KX N6D0474KX N6D0506KX N6E0078KX N6E0099KX N6E0117KX N6E0129KX N6E0366KX N6E0416KX N6F0039KX N6F0088KX N6F0156KX N6F0720KX N6F0780KX N6F0816KX N6G0099KX N6G0139KX N6G0191KX N6G0198KX N6G0213KX N6G0243KX N6G0280KX N6H0168KX N6H0247KX N6H0291KX N6H0327KX N6H0370KX N6H0433KX N6H0456KX N6H0466KX N6H0792KX N6H0827KX N6J0152KX N6J0185KX N6J0243KX N6J0476KX N6K0160KX N6K0209KX N6K0251KX N6K0293KX N6K0676KX N6K0739KX N6K0774KX N6K0824KX N6K0871KX N6K1137KX N6L0806KX N6L0814KRX N6L0909KX N6L0942KX N6L0944KX N6M0065KX N6M0095KX N6M0113KX N6M0134KX N6M0263KX N7A0293KX N7A0792KX N7B0070KX N7B0125KX N7B0154KX N7B0177KX N7B0885KX N7B0905KX N7B0946KX N7C0387KX N7C0405KX N7C0442KX N7C0485KX N7C0517KX N7C0775KX N7C0812KX N7C0857KX N7C0899KX N7C0927KX N7C0977KX N7C1014KX N7D0101KX N7D0135KX N7D0182KX N7D0226KX N7D0247KX N7D0264KX N7D0416KX N7D0473KX N7D0495KX N7D0538KX N7D0591KX N7D0918KX N7D0945KX N7E0372KX N7E0518KX N7E0565KX N7E0610KX N7E0920KX N7E0962KX N7F0093KX N7F0094KX N7F0186KX N7F0224KX N7F0662KX N7F0663KX N7F0696KX N7F0745KX N7F0822KX N7F1019KX N7F1052KX N7F1139KX N7G0016KX N7G0241KX N7G0279KX N7G0498KX N7G0790KX N7G0904KX N7H0012KX N7H0174KX N7H0315KX N7H0347KX N7H0419KX N7H0470KX N7H0520KX N7H0569KX N7H0712KX N7H0786KX N7H0957KX N7H1017KX N7H1057KX N7H1096KX N7H1141KX N7H1175KX N7H1187KX N7J0070KX N7J0099KX N7J0135KX N7J0174KX N7J0483KX N7J0508KX N7J0550KX N7J0636KX N7J0692KX N7J0858KX N7J0897KX N7J1014KX N7J1155KX N7K0008KX N7K0085KX N7K0087KX N7K0154KX N7K0225KX N7K0270KX N7K0272KX N7K0303KX N7K0307KX N7K0400KX N7K0443KX N7K0500KX N7K0544KX N7K0562KX N7K0711KX N7K0742KX N7K0783KX N7K0821KX N7K0904KX N7K0956KX N7K1052KX N7K1150KX N7K1181KX N7K1183KX N7L0057KX N7L0091KX N7L0132KX N7L0361KX N7L0403KX N7L0431KX N7L0475KX N7L0592KX N7L0811KX N7L0856KX N7L1004KX N7L1098KX N7M0100KX N7M0132KX N7M0506KX N7M0554KX N7M0589KX N7M0592KX N7M0614KX N7M0620KX N7M0778KX N7M0918KX N7M0967KX N7M1000KX N8A0065KX N8A0203KX N8A0380KX N8A0381KX N8A0772KX N8A0960KX N8A1028KX N8A1050KX N8A1099KX N8A1119KX N8B0114KX N8B0137KX N8B0204KX N8B0571KX N8B0641KX N8B0666KX N8B0709KX N8B0769KX N8B0805KX N8B0849KX N8B0885KX N8B0905KX N8B0958KX N8B1009KX N8B1034KX N8B1048KX N8C0159KX N8C0324KX N8C0340KX N8C0470KX N8C0546KX N8C0589KX N8C0718KX N8C0777KX N8C0779KX N8C0816KX N8C1338KX N8C1339KX N8D0043KX N8D0083KX N8D0142KX N8D0311KX N8D0312KX N8D0394KX N8D0482KX N8D0483KX N8D0536KX N8D0594KX N8D0647KX N8D0694KX N8D1045KX N8D1067KX N8E0081KX N8E0149KX N8E0201KX N8E0233KX N8E0266KX N8E0321KX N8E0378KX N8E0431KX N8E0435KX N8E0498KX N8E0567KX N8E0612KX N8E0659KX N8E0699KX N8E0700KX N8E0725KX N8F0094KX N8F0183KX N8F0258KX N8F0307KX N8F0335KX N8F0347KX N8F0383KX N8F0428KX N8F0482KX N8F0658KX N8F0691KX N8F0773KX N8F0858KX N8F0879KX N8F0921KX N8F0976KX N8F1015KX N8F1046KX N8G0871KX N8G0911KX N8G0942KX N8G0980KX N8H0683KX N8H0735KX N8H0759KX N8J0819KX N8L0895KY N8M0168KRY N9A0665KRY N9A0954KRY N9B0348KY 
Recalling Firm/
Manufacturer		 Covidien LLC
60 Middletown Ave
North Haven CT 06473-3908
For Additional Information Contact Customer Service
800-962-9888
Manufacturer Reason
for Recall		 The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.
FDA Determined
Cause 2		 Process control
Action All consignees were notified by letter delivered via Federal Express and/or certified mail beginning May 17, 2019. The letter informs customers of the recall of specific item codes and production lots of Covidien Endo GIA Articulating Reloads with Tri-Staple Technology due to the potential for a device to be missing one of two pin components that maintain alignment of the device jaws. Through this notification customers are instructed to take the following actions: " Immediately quarantine and discontinue use of the affected item codes and lots. " Return affected product. " Forward the information to anyone who they have distributed affected Covidien Endo GIA" Articulating Reloads with Tri-Staple Technology. " Complete the Recalled Product Return Form. 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 3,113,280
Distribution Nationwide domestic distribution, worldwide foreign 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
510(K)s with Product Code = GDW and Original Applicant = COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H
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