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Important Safety Information Concerning Pre-filled Saline and Heparin Syringes Manufactured by MedXL Inc. - Notice to Hospitals
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(PDF Version - 38 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 MedXL Inc.
Contact the company for a copy of any references, attachments or enclosures.
Notice to Hospitals
Health Canada Endorsed Important Safety Information on Prefilled Saline
and Heparin Syringes
March 27, 2009
To: Hospital Chief of Medical Staff
Please distribute to the relevant Departments of Surgery; Emergency Medicine, Pharmacy, Paediatrics, Anaesthesia, Geriatrics, Internal Medicine, Nursing, Intensive Care and/or other Departments as required and other involved professional staff and post this NOTICE in your institution.
Subject: Product Name: Prefilled Saline and Heparin Syringes
Cat. Number: 3704, 37043, 37043B, 37043BNC, 3705C, 3705NC, 3706, 3780, 3781, 3786, 3787
Lot Number: Lot numbers between 6892 and 8180
Dear Health Care Professional,
In collaboration with Health Canada, MedXL inc. would like to inform you that we have received complaints regarding the presence of visible particles and solution discoloration in our prefilled saline and heparin syringes. The probability of a clinician finding a defective syringe of this type in a lot of products is extremely small (approximately 12 defective syringes per million syringes manufactured). However the objective of this notice is to reinforce the importance of being vigilant and following all the instructions that are printed on the product package in order to avoid the accidental use of a defective prefilled syringe:
INSTRUCTIONS: Use aseptic technique. Visually inspect product for particulate matter and discoloration prior to use.
CAUTIONS: Do not use if the solution is discolored or contains a precipitate.
Please be advised that there have been no (zero) reported incidents or reported adverse reactions out of over 44 million prefilled syringes that have been manufactured by MedXL inc. In addition MedXL has implemented the necessary corrective actions to correct this problem.
Should you have any questions or needs for additional information regarding this advisory notice please do not hesitate to contact us at 514-695-7474 ext 103 or 514-695-7474 ext 139.
Managing marketed health product-related adverse incidents depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse incidents are generally presumed to underestimate the risks associated with health product treatments. Any cases of serious or unexpected adverse incidents in patients using prefilled saline and heparin syringes should be reported to MedXL Inc. or Health Canada at the following address:
285 Labrosse
Pointe Claire, Qc.
Canada H9R 1A3
Telephone: 514-695-7474
Fax: 514-695-1511
www.medxl.com
Any suspected adverse reaction can also be reported to:
Health Products and Food Branch Inspectorate
HEALTH CANADA
Address Locator: 2003D
Ottawa, Ontario K1A 0K9
Telephone: The Inspectorate Hotline 1-800-267-9675
The Medical Devices Problem Report Form and Guidelines can be found on 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
Telephone: 613-954-6522
Fax: 613-952-7738
Please rest assured that our objective is to manufacture Quality products which are designed for Healthcare professionals and that patient health and safety is very important to us. Thanking you for your collaboration in this matter.
Nassima Benguellil M.Sc.
Regulatory Affairs Manager
MedXL Inc.
