Various Medline Procedure Packs (2017-01-17)

Starting date:

January 17, 2017

Posting date:

February 9, 2017

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-62126

• Reason
• Affected products

Affected Products

1. Custom Procedure Kit/Tray
2. Surgical Set-Up Sure Set
3. Major Extremity Pack
4. Hand Pack
5. Basic Set Up Pack
6. Mini Pack
7. C - Section Pack
8. C Section Tray
9. Nasal/Ent Pack
10. Neuro - Crani Pack
11. Major Laparotomy
12. Lap Chole Pack
13. Laparoscopic Chole Pack
14. Laparoscopy Tray
15. Cabg Pack
16. Orthopedic Major Pack
17. Open Heart Pack
18. Heart Valve Pack
19. C-Section Cds Pack
20. Plateau A Cesarienne
21. Vgh Minor Vascular Pack
22. Basic Orthopaedic Pack Lf
23. Uro Perc Cds
24. Valve Pack
25. Shunt Pack
26. Craniotomy Pack
27. Spinal Pack
28. Abd. Aortic Aneurysm Pack
29. Acl Pack
30. Beach Chair Pack
31. Implant Pack
32. Major,Strl,F G Bjc Lf
33. Bariatr4ic Bjc Lf
34. Thoractomy Hsn Lf
35. Breast Pack Wrh Lf
36. Major Basic Wrh Lf
37. Minor Basic Wrh Lf
38. Vaginal Hysterectomy Wrh Lf
39. Tvt Pack Wrh Lf
40. Hip Knee Lf
41. Dental Pack Lf
42. Urology Major Pack Lf
43. Port A Cath Pacemaker Pack Lf
44. Orl Tympano Pack
45. Thyroid Pack
46. Head Pack
47. Operatiave Laparoscopy
48. Diagnostic Laparoscopy
49. Reduction Mammoplasty Pack
50. Robotics Pack Wrm-Lf
51. Major Plastic Pack Lh-Lf
52. Adult Hernia Lh-Lf
53. Minor Basic Lh-Lf
54. Minor Procedure Wo Drape Lh-Lf
55. Lap Chole Lh-Lf
56. Major General-Lf
57. Major General Lh-Lf
58. Adult Appendix Lh-Lf
59. Bone Retrieval Msh-Lf
60. Total Knee Lh-Lf
61. Hip Pk Lh-Lf
62. Dhs Versafix Lh-Lf
63. Ortho Plastic Limb Lh-Lf
64. Heart Recovery Msh-Lf
65. Thoracotomy Lh-Lf
66. Minor General Lh-Lf
67. Spinal Lh-Lf
68. Major Oral Lh-Lf
69. Vag Hysterectomy Lh-Lf
70. Tubal Ligation Lh-Lf
71. Operative Scope Lh-Lf
72. Percutaneous Nephro Lh-Lf
73. Peritoneal Dialysis Cath Lh-Lf
74. Major Urology Lh-Lf
75. Tvt Kit Lakeridge Lh-Lf
76. C Section Lh-Lf
77. Evar Pack
78. Tamponade Pack-Lf
79. Surgery Pack

Reason

Medline Industries received a recall notice from Medtronic concerning the Covidien Devon Light Glove. The light glove may split upon application to the Devon Light Handle Adapter. The light glove is a component in several Medline custom or procedure packs.

Affected products