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Urgent: Product Safety and Recall Notification regarding Smiths Medical CADD Medication Cassette Reservoirs - For Health Professionals
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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 Smiths Medical Canada Ltd.
Contact the company for a copy of any references, attachments or enclosures.
June 18, 2007
Subject: URGENT: PRODUCT SAFETY & RECALL NOTIFICATION
For: CADD® Medication Cassette Reservoirs
- 100-ml Medication Cassette Reservoir, Reorder No. 21-7002-24,
Lot Nos. 081X16 through 229X16 - 50-ml Medication Cassette Reservoir, Reorder No. 21-7001-24,
Lot Nos. 102X16 through 226X16 - 100-ml Medication Cassette Reservoir, Yellow,
Reorder No. 21-7100-24, Lot Nos. 083X16 through 225X16
Dear Customer,
Smiths Medical is voluntarily issuing this product recall notification for the above listed CADD® Medication Cassette Reservoirs ("Affected Cassettes"). Smiths Medical has become aware that an increase in pH may occur with some medications when instilled in the Affected Cassettes. Also, a small number of catheter occlusions have been reported from one customer in the United States when these Affected Cassettes have been used for delivering Flolan®.
An increase in pH of an instilled drug product may lead to degradation of the drug which could result in diminished drug efficacy.
Smiths Medical made a change to the reservoir bag material of the Cassettes in early 2006. The Affected Cassettes entered distribution to customers on June 9, 2006. Smiths Medical performed an extensive evaluation of this new bag material which showed the material to be biologically safe and substantially equivalent to the original bag material. Since that time, however, Smiths Medical has performed an investigation which has concluded that a slight difference in formulation of the new bag material is the root cause of the pH shift for some medications used in the Cassettes. Smiths Medical returned to manufacturing the Cassettes with the original bag material in January of 2007.
Smiths Medical believes that use of the Affected Cassettes presents a low risk of harm to patients. While there have been only a very small number of reports of issues arising from the use of Cassette with the new bag material and these reports may or may not be related to this material change, Smiths Medical is proceeding with this voluntary recall action. As a precaution Smiths Medical is requiring its customers to return to Smiths Medical all unused Affected Cassettes.
Cassettes with lot numbers below 081X16 and lot numbers ending in nnnX17 are not affected by this recall.
Please contact the Smiths Medical Canada, Regulatory Affairs Department at 905-477-2000 ext 135 to make arrangements to return the unused product. Smiths Medical will provide replacement product when product is available or offer credit.
Also, in order for Smiths Medical to best assist its customers, please complete and return the fax confirmation of this safety alert found in Attachment 1 of this letter.
Smiths Medical Canada Ltd.
301 Gough Road
Markham, ON
L3R 4Y8
Tel.: 905-477-2000
Fax: 905-477-2144
Any suspected adverse reaction 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 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
Tel: 613-954-6522
Fax: 613-952-7738
If you should have any questions regarding this issue, please contact Smiths Medical Regulatory Affairs at 905-477-2000 ext 135.
Sincerely,
original signed by
John Bordin
Senior Vice President, Finance & Administration
Attachment 1
Smiths Medical Canada Ltd.
301 Gough Road
Markham, ON
L3R 4Y8
PRODUCT RECALL
CADD® Medication Cassette Reservoirs
- 100-ml Medication Cassette Reservoir, Reorder No. 21-7002-24,
Lot Nos. 081X16 through 229X16 - 50-ml Medication Cassette Reservoir, Reorder No. 21-7001-24,
Lot Nos. 102X16 through 226X16 - 100-ml Medication Cassette Reservoir, Yellow,
Reorder No. 21-7100-24,
Lot Nos. 083X16 through 225X16
Upon completing the following information, please fax this sheet to the Smiths Medical Canada Ltd. Regulatory Affairs Department at 905-477-2144.
Please check all of the relevant boxes, which relate to your affected product inventory:
Check the relevant box
If yes, how many, Reorder No. and Lot No.?
NO, I have no affected inventory of Cassettes remaining. All affected Cassettes have been used or discarded.
YES, I have unused affected inventory of Cassettes remaining that I will return for replacement or credit. Please call Smiths Medical Regulatory Affairs at 905-477-2000 ext 135 to arrange return of the product.
Reorder No.
Lot No.
Quantity:
Please write on an additional sheet if necessary.
Note: The answers to these questions help Smiths Medical best assist you with replacement product.
Customer Name:
Address:
Phone Number:
Customer Signature
Date
