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U.S. Department of Health and Human Services

Class 2 Device Recall Covidien Auto Suture" Blunt Tip Trocar

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  Class 2 Device Recall Covidien Auto Suture" Blunt Tip Trocar see related information
Date Initiated by Firm February 28, 2024
Date Posted April 03, 2024
Recall Status1 Open3, Classified
Recall Number Z-1470-2024
Recall Event ID 94131
510(K)Number K924011  
Product Classification Laparoscope, general & plastic surgery - Product Code GCJ
Product Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BT
Code Information Product Number/CFN: OMS-T10BT; UDI/DI: 10884521080874, 20884521080871; Lot Serial Number: P1D1353, P1D1353, P1D1355, P1D1409, P1D1410, P1D1506, P1D1506, P1D1507, P1D1507, P1E1402, P1E1402, P1E1403, P1E1403, P1E1505, P1E1505, P1E1506, P1E1506, P1F0061, P1F0061, P1F0062, P1F0062, P1F0063, P1F1018, P1F1018, P1F1019, P1F1388, P1F1388, P1F1546, P1G0140, P1G0140, P1G1117, P1G1117, P1G1119, P1G1119, P1G1121, P1G1121, P1G1364, P1G1364, P1H0049, P1H0049, P1H0421, P1H0527Q, P1H0527Q, P1H0859, P1H0859, P1H0860, P1H0860, P1J1272, P1J1321, P1J1321, P1J1339, P1J1339, P1J1342, P1J1342, P1K0179, P1K0179, P1K0180, P1K0180, P1K0182, P1K0182, P1K0353, P1K0353, P1K0560, P1K0560, P1K0561, P1K0561, P1K0589, P1K0589, P1L0490, P1L0490, P1L0681, P1L0681, P1L0705, P1L0705, P1L0976, P1L0976, P1M0021, P1M0021, P1M0022, P1M0744, P1M0744, P1M0745, P1M0970, P1M0971, P1M1151, P1M1152, P2A0118, P2A0118, P2B0028Q, P2B0137, P2B0137, P2B0139, P2B0139, P2B0308, P2B0745, P2B0745, P2B0912, P2B0912, P2B0913, P2B0913, P2C0175, P2C0175, P2C0178, P2C0643, P2C0643, P2C0758, P2C0758, P2C0764, P2C0765, P2C0765, P2C0877, P2C0877, P2C0878, P2C0878, P2D0231, P2D0231, P2D0232, P2D0232, P2D0373, P2D0373, P2D0374, P2D0374, P2D0415, P2D0415, P2D0539, P2D0539, P2D0540, P2D0540, P2E0244, P2E0244, P2E0245, P2E0371, P2E0371, P2F0041, P2F0041, P2F0042, P2F0133, P2F0133, P2F0134, P2F0134, P2F0135, P2F0135, P2F0449, P2F0449, P2F0450, P2F0450, P2F0451, P2F0451, P2F0452, P2F0452, P2F0453, P2F0453, P2F0454, P2F0454, P2G0141Q, P2G0533, P2G0533, P2H0085, P2H0085, P2H0142, P2H0142, P2H0419, P2H0419, P2H0570, P2H0570, P2J0081, P2J0081, P2J0362, P2J0362, P2J0442, P2J0442, P2J0443, P2J0443, P2J0460, P2J0460, P2K0080, P2K0080, P2K0123, P2K0123, P2K0432, P2K0432, P2K0565, P2K0565, P2L0554, P2L0554, P2L0555, P2L0555, P2L0556, P2L0556, P2M0032, P2M0408, P2M0408, P2M0409, P2M0410, P2M0410, P2M0411, P2M0411, P3A0084, P3A0084, P3A0085, P3A0086, P3A0086, P3A0087, P3A0271, P3A0271, P3A0272, P3A0272, P3A0273, P3A0273, P3A0277, P3A0277, P3A0278, P3A0278, P3A0279, P3A0279, P3B0075, P3B0075, P3B0147, P3B0147, P3B0158, P3B0158, P3B0162Q, P3D0121, P3D0121, P3D0122, P3D0122, P3D0150, P3D0150, P3D0151, P3D0151, P3D0152, P3D0152, P3D0399, P3D0400, P3D0400, P3D0401, P3D0401, P3E0294, P3E0294, P3E0295, P3E0295, P3E0315, P3E0315, P3E0369, P3E0369, P3F0461, P3F0461, P3F0462, P3F0462, P3H1033, P3H1033, P3H1034, P3H1193, P3H1193, P3H1194, P3H1194, P3H1195, P3H1195, P3J0855, P3J0855, P3J0856, P3J0857, P3J0857, P3J1100, P3J1100, P3J1101, P3J1101, P3J1102, P3J1103, P3J1103, P3K0951, P3K1067, P3K1068, P3K1069, P3K1243, P3K1244, P3K1339, P3K1340, P3L0889, P3L0890;
Recalling Firm/
Manufacturer		 Covidien, LP
60 Middletown Ave
North Haven CT 06473-3908
For Additional Information Contact Kati Salefski
508-452-4894
Manufacturer Reason
for Recall		 The potential for trocar seal disengagement when using mesh products incorrectly with the device.
FDA Determined
Cause 2		 Labeling design
Action On February 28, 2024, the firm notified customers of the issue via URGENT: MEDICAL DEVICE RECALL letters. Actions to be taken by the customer: 1. Inform all surgeons and clinicians who handle the preparation and/ or placement of a Mesh Device that utilize the balloon and blunt tip trocar devices. 2. Prior to using any Mesh device in conjunction with the following Trocars: Covidien Auto Suture" Structural Balloon Trocar and Auto Suture" Blunt Tip Trocar, please carefully review and adhere to the mesh manufacturer s Instructions for Use (IFU) on proper insertion techniques. 3. Please complete and return the customer confirmation form enclosed with this letter acknowledging receipt of this information via email to rs.gmbmitgfca@medtronic.com. 4. Please transfer this notice to other organizations on which this action has an impact and maintain a copy of this notice in your records. Adverse events or quality problems experienced with this product should be reported to the FDA and Medtronic: Online at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm, or call FDA at 1-800-FDA-1088 (1-800-332-1088) and Medtronic Vascular Customer Service at 800-716-6700. 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.
Quantity in Commerce 165,356 units
Distribution Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Aruba, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, French Guiana, French Polynesia, Germany, Gibraltar, Greece, Guadeloupe, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Republic Of, Luxembourg, Macao, Malaysia, Malta, Martinique, Mayotte, Mexico, Netherlands, New Caledonia, New Zealand, Nigeria, Northern Ireland, Norway, Oman, Poland, Portugal, Puerto Rico, Reunion, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Turkey, United Arab Emirates, United Kingdom, United States, Uzbekistan, Viet Nam, Virgin Islands, U.S.;
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 = GCJ and Original Applicant = ORIGIN MEDSYSTEMS, INC.
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