Reported May 1, 2019 · Terminated
Procedure kits include devices from the affected lots distributed OUS only
Covidien LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: COVIDIEN LLC · 15 Hampshire St · Mansfield, MA · 02048-1113
Is this the product you have?
Procedure kits include devices from the affected lots distributed OUS only
36 of 36 products
| Model / number | Product as published |
|---|---|
(2)BOX | Procedure kits include devices from the affected lots distributed OUS only: (1)BOX KIT00529H KIT COLECISTECTOMIA ACCESO |
(5)BOX | KIT00680 KIT COLECISTECTOMIA- (3)BOX KIT00681 KIT APENDICECTOMIA (4)BOX KIT00897 KIT COLON IZQUIERDO |
(6)BOX | LAPL1 ZESTAW DO CHOLECYSTEKTOMII |
(7)KIT00599 | PST01134 LAP CHOLE KIT ST JOHN S |
(8)KIT00608 | LAPARO GENERICO X1 |
(9)KIT2176CV | APENDICECTOMIA LAP X1 |
(10)KIT2951V | BORNHOLM LAP INGUINAL HERNIA |
(11KIT2963 | CHOLECYSTECT BORNHOLM |
(12)KITM025 | APPENDECTOMY KIT X1 |
0217134109 | 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 |
0217118761 | (5)BOX LAPL1 ZESTAW DO CHOLECYSTEKTOMII |
0217119261 | (6)BOX PST01134 LAP CHOLE KIT ST JOHN S |
0217130753 | 0217119259 (7)KIT00599 LAPARO GENERICO X1 |
0217132887 | 0217130754 (8)KIT00608 APENDICECTOMIA LAP X1 |
0217123007 | (9)KIT2176CV BORNHOLM LAP INGUINAL HERNIA |
0217123010 | (10)KIT2951V CHOLECYSTECT BORNHOLM |
0217123009 | (11KIT2963 APPENDECTOMY KIT X1 |
0217127223 | (12)KITM025 M'LANDS MR NASSAR LAP CHOLEX1 |
0217134109 | 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 |
0217118761 | (5)BOX LAPL1 ZESTAW DO CHOLECYSTEKTOMII |
- Lot codes and dates
- (1)BOX KIT00529H
- KIT COLECISTECTOMIA ACCESO Lot Number0217118756 (2)BOX KIT00680
- KIT COLECISTECTOMIA- Lot Numbers(3)BOX
0217117865021711874602171178630217117858021711786402171178620217117861021711785902171178570217117860
- KIT00681 KIT APENDICECTOMIA Lot Numbers0217118750 0217118749 0217118748 0217118747 (4)BOX
- KIT00897 KIT COLON IZQUIERDO Lot Number0217134109 (5)BOX
- LAPL1 ZESTAW DO CHOLECYSTEKTOMII Lot No0217118761 (6)BOX PST01134
- LAP CHOLE KIT ST JOHN S Lot numbers
:02171192610217119259 (7)KIT00599
- LAPARO GENERICO X1 Lot Numbers0217130753, 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 Number0217118756 (2)BOX KIT00680 KIT COLECISTECTOMIA-(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
0217117865021711874602171178630217117858021711786402171178620217117861021711785902171178570217117860
- KIT COLECISTECTOMIA ACCESO Lot Number0217118756 (2)BOX KIT00680 KIT COLECISTECTOMIA-(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
0217117865021711874602171178630217117858021711786402171178620217117861021711785902171178570217117860
- KIT COLECISTECTOMIA ACCESO Lot Number0217118756 (2)BOX KIT00680 KIT COLECISTECTOMIA-(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
0217117865021711874602171178630217117858021711786402171178620217117861021711785902171178570217117860
- Amount recalled
- 148 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Sterilization method used was not consistent with the labeling and the approved sterilization method
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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