Recall record at a glance
| Official record | Z-1213-2019 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | COVIDIEN LLC |
| Report date | May 1, 2019 |
| Recall initiation date | Mar 13, 2019 |
| Quantity | 148 units |
| Location | Mansfield, MA, United States |
Official product description
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
Why the product was recalled
Sterilization method used was not consistent with the labeling and the approved sterilization method
Distribution information
Worldwide Distribution: US (Nationwide) and to countries of: Canada, Chile, Costa Rica, Guatemala, Japan, Mexico, Panama, Slovakia, Spain, Switzerland and Turkey.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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