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U.S. Department of Health and Human Services

Class 2 Device Recall Covidien Procedure kits

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  Class 2 Device Recall Covidien Procedure kits see related information
Date Initiated by Firm March 13, 2019
Create Date April 23, 2019
Recall Status1 Terminated 3 on April 23, 2020
Recall Number Z-1213-2019
Recall Event ID 82426
510(K)Number K903205  
Product Classification Forceps, obstetrical - Product Code HDA
Product Procedure kits include devices from the affected lots distributed OUS only:
(1)BOX KIT00529H KIT COLECISTECTOMIA ACCESO
(2)BOX KIT00680 KIT COLECISTECTOMIA-
(3)BOX KIT00681 KIT APENDICECTOMIA
(4)BOX KIT00897 KIT COLON IZQUIERDO
(5)BOX LAPL1 ZESTAW DO CHOLECYSTEKTOMII
(6)BOX PST01134 LAP CHOLE KIT ST JOHN S
(7)KIT00599 LAPARO GENERICO X1
(8)KIT00608 APENDICECTOMIA LAP X1
(9)KIT2176CV BORNHOLM LAP INGUINAL HERNIA
(10)KIT2951V CHOLECYSTECT BORNHOLM
(11KIT2963 APPENDECTOMY KIT X1 (12)KITM025 M'LANDS MR NASSAR LAP CHOLEX1

The Covidien Endo Grasp" Auto Suture" grasper 5 mm instrument has applications in a variety of gynecologic, general, urologic, thoracic and endoscopic procedures for temporary grasping/clamping of tissue and small tubular structures.



























1)BOX KIT00529H KIT COLECISTECTOMIA ACCESO
Lot Number: 0217118756
(2)BOX KIT00680 KIT COLECISTECTOMIA-
0217117865
0217118746
0217117863
0217117858
0217117864
0217117862
0217117861
0217117859
0217117857
0217117860

(3)BOX KIT00681 KIT APENDICECTOMIA
0217118750
0217118749
0217118748
0217118747

(4)BOX KIT00897 KIT COLON IZQUIERDO 0217134109

(5)BOX LAPL1 ZESTAW DO CHOLECYSTEKTOMII 0217118761
(6)BOX PST01134 LAP CHOLE KIT ST JOHN S 0217119261, 0217119259
(7)KIT00599 LAPARO GENERICO X1 0217130753, 0217130754
(8)KIT00608 APENDICECTOMIA LAP X1 0217132887
(9)KIT2176CV BORNHOLM LAP INGUINAL HERNIA 0217123007
(10)KIT2951V CHOLECYSTECT BORNHOLM 0217123010
(11KIT2963 APPENDECTOMY KIT X1 0217123009
(12)KITM025 M'LANDS MR NASSAR LAP CHOLEX1 0217127223















(1)BOX KIT00529H KIT COLECISTECTOMIA ACCESO
Lot Number: 0217118756
(2)BOX KIT00680 KIT COLECISTECTOMIA-
0217117865
0217118746
0217117863
0217117858
0217117864
0217117862
0217117861
0217117859
0217117857
0217117860

(3)BOX KIT00681 KIT APENDICECTOMIA
0217118750
0217118749
0217118748
0217118747

(4)BOX KIT00897 KIT COLON IZQUIERDO 0217134109

(5)BOX LAPL1 ZESTAW DO CHOLECYSTEKTOMII 0217118761
(6)BOX PST01134 LAP CHOLE KIT ST JOHN S 0217119261, 0217119259
(7)KIT00599 LAPARO GENERICO X1 0217130753, 0217130754
(8)KIT00608 APENDICECTOMIA LAP X1 0217132887
(9)KIT2176CV BORNHOLM LAP INGUINAL HERNIA 0217123007
(10)KIT2951V CHOLECYSTECT BORNHOLM 0217123010
(11KIT2963 APPENDECTOMY KIT X1 0217123009
(12)KITM025 M'LANDS MR NASSAR LAP CHOLEX1 0217127223









(1)BOX KIT00529H KIT COLECISTECTOMIA ACCESO
Lot Number: 0217118756
(2)BOX KIT00680 KIT COLECISTECTOMIA-
0217117865
0217118746
0217117863
0217117858
0217117864
0217117862
0217117861
0217117859
0217117857
0217117860

(3)BOX KIT00681 KIT APENDICECTOMIA
0217118750
0217118749
0217118748
0217118747

(4)BOX KIT00897 KIT COLON IZQUIERDO 0217134109

(5)BOX LAPL1 ZESTAW DO CHOLECYSTEKTOMII 0217118761
(6)BOX PST01134 LAP CHOLE KIT ST JOHN S 0217119261, 0217119259
(7)KIT00599 LAPARO GENERICO X1 0217130753, 0217130754
(8)KIT00608 APENDICECTOMIA LAP X1 0217132887
(9)KIT2176CV BORNHOLM LAP INGUINAL HERNIA 0217123007
(10)KIT2951V CHOLECYSTECT BORNHOLM 0217123010
(11KIT2963 APPENDECTOMY KIT X1 0217123009
(12)KITM025 M'LANDS MR NASSAR LAP CHOLEX1 0217127223
Code Information (1)BOX KIT00529H KIT COLECISTECTOMIA ACCESO  Lot Number: 0217118756 (2)BOX KIT00680 KIT COLECISTECTOMIA- Lot Numbers: 0217117865 0217118746 0217117863 0217117858 0217117864 0217117862 0217117861 0217117859 0217117857 0217117860  (3)BOX KIT00681 KIT APENDICECTOMIA Lot Numbers: 0217118750 0217118749 0217118748 0217118747  (4)BOX KIT00897 KIT COLON IZQUIERDO Lot Number: 0217134109  (5)BOX LAPL1 ZESTAW DO CHOLECYSTEKTOMII Lot No: 0217118761 (6)BOX PST01134 LAP CHOLE KIT ST JOHN S  Lot numbers: :0217119261, 0217119259 (7)KIT00599 LAPARO GENERICO X1  Lot Numbers: 0217130753, 0217130754 (8)KIT00608 APENDICECTOMIA LAP X1 Lot No. 0217132887 (9)KIT2176CV BORNHOLM LAP INGUINAL HERNIA Lot No.0217123007 (10)KIT2951V CHOLECYSTECT BORNHOLM Lot No. 0217123010 (11KIT2963 APPENDECTOMY KIT X1 Lot No. 0217123009 (12)KITM025 M'LANDS MR NASSAR LAP CHOLEX1 Lot No. 0217127223                             1)BOX KIT00529H KIT COLECISTECTOMIA ACCESO  Lot Number: 0217118756 (2)BOX KIT00680 KIT COLECISTECTOMIA- 0217117865 0217118746 0217117863 0217117858 0217117864 0217117862 0217117861 0217117859 0217117857 0217117860  (3)BOX KIT00681 KIT APENDICECTOMIA 0217118750 0217118749 0217118748 0217118747  (4)BOX KIT00897 KIT COLON IZQUIERDO 0217134109  (5)BOX LAPL1 ZESTAW DO CHOLECYSTEKTOMII 0217118761 (6)BOX PST01134 LAP CHOLE KIT ST JOHN S 0217119261, 0217119259 (7)KIT00599 LAPARO GENERICO X1 0217130753, 0217130754 (8)KIT00608 APENDICECTOMIA LAP X1 0217132887 (9)KIT2176CV BORNHOLM LAP INGUINAL HERNIA 0217123007 (10)KIT2951V CHOLECYSTECT BORNHOLM 0217123010 (11KIT2963 APPENDECTOMY KIT X1 0217123009 (12)KITM025 M'LANDS MR NASSAR LAP CHOLEX1 0217127223                (1)BOX KIT00529H KIT COLECISTECTOMIA ACCESO  Lot Number: 0217118756 (2)BOX KIT00680 KIT COLECISTECTOMIA- 0217117865 0217118746 0217117863 0217117858 0217117864 0217117862 0217117861 0217117859 0217117857 0217117860  (3)BOX KIT00681 KIT APENDICECTOMIA 0217118750 0217118749 0217118748 0217118747  (4)BOX KIT00897 KIT COLON IZQUIERDO 0217134109  (5)BOX LAPL1 ZESTAW DO CHOLECYSTEKTOMII 0217118761 (6)BOX PST01134 LAP CHOLE KIT ST JOHN S 0217119261, 0217119259 (7)KIT00599 LAPARO GENERICO X1 0217130753, 0217130754 (8)KIT00608 APENDICECTOMIA LAP X1 0217132887 (9)KIT2176CV BORNHOLM LAP INGUINAL HERNIA 0217123007 (10)KIT2951V CHOLECYSTECT BORNHOLM 0217123010 (11KIT2963 APPENDECTOMY KIT X1 0217123009 (12)KITM025 M'LANDS MR NASSAR LAP CHOLEX1 0217127223          (1)BOX KIT00529H KIT COLECISTECTOMIA ACCESO  Lot Number: 0217118756 (2)BOX KIT00680 KIT COLECISTECTOMIA- 0217117865 0217118746 0217117863 0217117858 0217117864 0217117862 0217117861 0217117859 0217117857 0217117860  (3)BOX KIT00681 KIT APENDICECTOMIA 0217118750 0217118749 0217118748 0217118747  (4)BOX KIT00897 KIT COLON IZQUIERDO 0217134109  (5)BOX LAPL1 ZESTAW DO CHOLECYSTEKTOMII 0217118761 (6)BOX PST01134 LAP CHOLE KIT ST JOHN S 0217119261, 0217119259 (7)KIT00599 LAPARO GENERICO X1 0217130753, 0217130754 (8)KIT00608 APENDICECTOMIA LAP X1 0217132887 (9)KIT2176CV BORNHOLM LAP INGUINAL HERNIA 0217123007 (10)KIT2951V CHOLECYSTECT BORNHOLM 0217123010 (11KIT2963 APPENDECTOMY KIT X1 0217123009 (12)KITM025 M'LANDS MR NASSAR LAP CHOLEX1 0217127223           
Recalling Firm/
Manufacturer		 COVIDIEN LLC
15 Hampshire St
Mansfield MA 02048-1113
For Additional Information Contact SAME
508-261-8000
Manufacturer Reason
for Recall		 Sterilization method used was not consistent with the labeling and the approved sterilization method
FDA Determined
Cause 2		 Process control
Action Medtronic notified consignees via an "URGENT MEDICAL DEVICE RECALL" letter by Federal Express and/or certified mail on March 13, 2019. The letter informs customers of the recall of twenty-one production lot of Covidien Endo Clinch" and Endo Grasp" Auto Suture" graspers 5mm as the sterilization method used for these lots was not consistent with the labeling and the approved sterilization method. Customers are instructed to take the following actions: 1. Please immediately quarantine and discontinue use of the affected item codes and lots listed above. 2. Please return affected product as indicated below. 3. If you have distributed the Endo Clinch" II or Endo Grasp" Auto Suture" graspers 5mm listed above, 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 inventory email to: feedback.customerservice@covidien.com fax to: 800-895-6140. -----Exception: Customers with zero inventory, fax to 203-492-7719 or email to GMBFCAMITG@Medtronic.com If purchased by distributor, fax to 203-492-7719 or email GMBFCAMITG@Medtronic.com. If you have any questions or concerns, please do not hesitate to contact your Medtronic representative or Customer Service at 800-962-9888, option 2.
Quantity in Commerce 148 units
Distribution Worldwide Distribution: US (Nationwide) and to countries of: Canada, Chile, Costa Rica, Guatemala, Japan, Mexico, Panama, Slovakia, Spain, Switzerland and Turkey.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HDA and Original Applicant = UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
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