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Important safety information to users of Liko Universal SlingBar - Notice to Hospitals
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(PDF Version - 245 K)Contact: Marketed Health Products Directorate (MHPD)
The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.
This is duplicated text of a letter from Peridot Medical Inc.
Contact the company for a copy of any references, attachments or enclosures.
NOTICE TO HOSPITALS
Health Canada Endorsed Important Safety Information on
Liko Universal SlingBar
June 2, 2008
To: Hospital Chief of Medical Staff
Please distribute to the relevant Departments of [Surgery; Emergency Medecine, Pharmacy, Pediatrics, Anesthesia, Geriatrics, Internal Medicine, Nursing, Dentistry, Intensive Care and/or other Departments as required] and other involved professional staff and post this NOTICE in your institution.
Subject: Field Safety Notice - Important safety information to users of Liko Universal SlingBar
Dear Customer,
Liko AB has initiated a field correction program for its product, the “Universal SlingBar”, according to the list below.
When mounted on Viking or LikoLight mobile lifts, a component securing the Universal SlingBar to the lift, in certain circumstances, may experience unanticipated fatigue. In extreme cases this can result in the sling bar becoming detached from the mobile lift. If this were to happen when a patient was being lifted, the patient would risk falling. To date, Liko AB has had no report of personal injuries.
However, as an industry leader in developing safe lifting equipment and as an advocate for quality and safety, Liko AB does not accept products that do not live up Liko AB’s quality standards. Therefore Liko AB has made the voluntary decision to launch a field correction program to replace all affected products with a new sling bar design. All sling bars now being delivered from Liko AB are the new design.
Accompanying this Field Safety Notice is a letter from Peridot Medical Inc., your national Liko product distributor explaining how and when they will contact you to exchange your affected sling bars. In the mean time, your lifting equipment is safe to use, as long as the sling bar passes the inspection described on the next page. If your sling bar does not pass the inspection, or if you are not sure of how to perform the inspection, please contact Peridot Medical Inc. at 1-800-306-5438 for more information.
Thank you for your attention and cooperation in this matter. We sincerely apologize for any inconvenience this may cause you.
| Affected Products | Product no. | Only in combination with lift(s) |
|---|---|---|
| Universal SlingBar 350 | 3156074 | Viking XS, Viking S, Viking M, Viking L, LikoLight |
| Universal SlingBar 450 | 3156075 | |
| Universal SlingBar 600 | 3156076 | |
| Universal SlingBar 350 with Quick-release Hook | 3156084 | In combination with all lifts from Liko, i.e. mobile lifts and overhead lifts. |
| Universal SlingBar 450 with Quick-release Hook | 3156085 | |
| Universal SlingBar 600 with Quick-release Hook | 3156086 |
Affected serial numbers on sling bars: 1200101-1245680, 121204-121499, 12222407-12225241
Note: Universal SlingBar 350, 450, 600 (without Quick-release Hook) mounted on overhead lifts or the mobile lift Golvo (using lift straps) is NOT affected. Universal SlingBars with Quick-release Hooks are included in the program due to the fact that they easily can be transferred and mounted on to Viking or LikoLight mobile lifts.
Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-market adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any cases of detachment of Liko Universal Slingbar or other serious or unexpected incident associated with the use of Liko Universal Slingbar should be reported to Peridot Medical Inc. (Canada) or Health Canada at the following addresses:
Peridot Medical Inc.
Phone: 1-800-306-5438
Any suspected adverse incident can also be reported to:
Health Products and Food Branch Inspectorate
HEALTH CANADA
Address Locator: 2003D
Ottawa, Ontario K1A 0K9
Tel: The Inspectorate Hotline 1-800-267-9675
The Reporting Form and Guidelines can be obtained from the Health Canada web site.
For other inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate (MHPD)
E-mail: MHPD_DPSC@hc-sc.gc.ca
Tel.: 613-954-6522
Fax: 613-952-7738
original signed by
William Verrall
President and CEO
Safety Inspection for the Universal SlingBar
This inspection should be performed before every lift, until you receive a replacement sling bar. If the gap between the plastic cover and the sling bar is wider than the thickness of the Hook on the Hand control for a mobile lift (4mm or .16 inch), IMMEDIATELY take the sling bar out of service.
Universal SlingBar 350, 450, 600 (without Quick-release Hook)
Universal SlingBar 350, 450, 600 with Quick-release Hook
If your Universal SlingBar is the new design, there is no need to perform the safety inspection:
Old Version
New design version
The new design of Universal SlingBar has a mark to visibly separate it from the old version.
