Various Medline Procedure Packs (2017-01-23)

Starting date:

January 23, 2017

Posting date:

February 27, 2017

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

Healthcare Professionals, General Public, Hospitals

Identification number:

RA-62380

• Reason
• Affected products

Affected Products

1. C - Section Pack
2. Cath Lab Angiogram Tray
3. Laceration Tray
4. Spine Pack
5. Angio Radiograph
6. Hysterectomy Pack
7. Pacemaker Pack
8. C-Section Cds Pack
9. Vaginal Delivery Cds Pack
10. Knee Arthroplasty Pack
11. Gen Urology Major - Pediatric
12. Gen Urology Minor
13. Gen Urology / Gyn Lap Pack
14. Minor Plastics Tray
15. Apu Av Fistula Pack
16. General Minor Pack Lf
17. General Major Pack - Lf
18. Urology Laparoscopic Pack
19. Minor Procedure Cds Pack
20. Ptca Kit
21. Jpocsc Pacemaker Pack-Lf
22. Open Heart Bypass Hsn Lf
23. Left Heart Kit Hdgh Lf
24. Av Fistula Hdgh Lf
25. Biopsy Hdgh Lf
26. Biopsy With Probe Conver Hdgh Lf
27. Minor Gyne Pack Ckhas Lf
28. Tvt Pack Smgh Lf
29. Foot Toe Pack Lf
30. Picc Line Insertion Lf
31. Angiogram Lf
32. Thoracotomy Sjhc-Lf
33. Robotic Lap Prostatect Tegh-Lf
34. Lap Chole Tegh-Lf
35. Lap Chole Rvhs-Lf
36. Thoracoscopy, Strl F G Tegh-Lf
37. Minor Procedure Rvhs-Lf
38. Breast Biopsy Wch-Lf
39. Bottom End 2 Team Wch-Lf
40. Axilla Wch-Lf
41. Thoracoscopy Sjhc-Lf
42. Shoulder Tegh-Lf
43. Shoulder Rvhs-Lf
44. Major Limb Rvhs-Lf
45. Minor Limb Rvhs-Lf
46. Bent Leg Arthro. Rvhs-Lf
47. Block Kit-Lf
48. Shoulder Sjhc-Lf
49. Pacemaker Tegh-Lf
50. Left Heart Cath Tegh-Lf
51. Cath Radial Shsc-Lf
52. Left Heart Cath Twh-Lf
53. Left Heart Cath Tgh-Lf
54. Lft Hrt Cath Radial Access-Lf
55. Pacemaker Sjhc-Lf
56. Major Nasal Surgery Tegh-Lf
57. Endonasal Dcr Msh-Lf
58. Glossectomy Msh-Lf
59. Tmj Msh-Lf
60. Vag Hys Ant Pst Repair Tegh-Lf
61. Vaginal Hysterectomy Rvhs-Lf
62. Laparoscopy Lithotomy Sjhc-Lf
63. Lithotomy Sjhc-Lf
64. Tvt Kit Lakeridge Lh-Lf
65. Tvt Wch-Lf
66. Eops Vasovasostomy Msh-Lf
67. Minor Urology Msh-Lf
68. Vasovasostomy Msh-Lf
69. Circumcision Sjhc-Lf
70. Laparoscopy Rvhs-Lf
71. Major Laparoscopic Sjhc-Lf
72. Minor Laparoscopic Sjhc-Lf
73. C Section Tegh-Lf
74. C Section Lh-Lf
75. Labour Delivery Sjhc-Lf
76. C Section Sjhc-Lf
77. Hysteroscopy Pack Ckha-Lf

Reason

Medline Industries received a product advisory notice from BD concerning their eclipse needle. BD has received reports of safety cover disengagement and needlestick injury (NSI) for the BD eclipse needle. Based on the customer reports, in some cases when the safety cover is pushed over the needle it disengages, resulting in an exposed needle which can increase the risk of NSI. The BD eclipse needle is a component in several Medline custom procedure packs. Medline Canada is therefore informing its customers of the BD advisory notice.

Affected products