Level 1 Normothermic I.V. Fluid Administration Sets (Product Codes D-60 HL and DI-60 HL) heat exchanger assembly manufacturing issue - Recall - Notice to Hospitals

Contact: Marketed Health Products Directorate

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.

NOTICE TO HOSPITALS
Health Canada Endorsed Important Safety Information on Level 1 Normothermic I.V. Fluid Administration Sets, Product Codes D-60HL and DI-60HL

October 4, 2010

To whom this may concern:

Please distribute to relevant Departments (Surgery, Emergency Medicine, 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: Recall - Level 1^® Normothermic I.V. Fluid Administration Sets (Product Codes D-60 HL and DI-60 HL) heat exchanger assembly manufacturing issue.

Smiths Medical, in collaboration with Health Canada, is conducting a voluntary recall of a limited number of Level 1^® Normothermic I.V. Fluid Administration Sets, Product Codes D-60HL and DI-60HL ("Disposable Sets").

Affected lot numbers:

D-60 HL:
1208297, 1212856, 1212857, 1215601, 1221992, 1221998, 1224514, 1247148, 1269236, 1273882

DI-60 HL:
1202019, 1202020, 1202021, 1202022, 1202023, 1212858, 1212859, 1212860, 1215578, 1215579, 1215580, 1222004, 1222005, 1222006, 1224524, 1224525, 1224526, 1224527, 1224528, 1224529, 1224530, 1224533, 1224534, 1224535, 1224536, 1224532, 1224531, 1224537, 1224538, 1224334, 1224332, 1234235, 1243223, 1273868, 1273878, 1273871, 1273872, 1273869, 1273870, 1273874

Smiths Medical has become aware of a manufacturing issue and has found that some of the heat exchanger assemblies in these Disposable Sets may be too long and therefore, may not fit into Level 1^® Fast Flow Fluid Warmers, making the Disposable Set unusable. This could potentially result in treatment delays while another Disposable Set is obtained or an alternative method of fluid warming is obtained. Some customers have noticed this issue when they received an audible and visual "Check Disposable" alarm when attempting to install the Disposable Sets. This Urgent Recall Notice only applies to Lot Numbers listed above.

There has been a report of patient death associated with the inability to find and properly utilize a Disposable Set during an emergency blood transfusion involving multiple units of blood.

Action to be taken by the user:

To return affected Disposable Sets or for questions regarding this Urgent Recall Notice, please contact our Regulatory Affairs Department, Chinh Luu, Regulatory Affairs Associate, Smiths Medical Canada, Ltd. at 905-477-2000 ext. 173.

Please report any issues with these Disposable Sets to the Regulatory Affairs Department, Chinh Luu, Regulatory Affairs Associate, Smiths Medical Canada, Ltd. at 905-477-2000 ext. 173 or email to chinh.luu@smiths-medical.com.

If you or your facility has distributed these affected Disposable Sets to other persons or facilities, please promptly forward the recipients a copy of this Urgent Recall Notice.

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-market adverse incidents are generally presumed to underestimate the risks associated with health product treatments. Any cases of serious unexpected adverse incidents for medical devices in patients using Level 1^® Normothermic I.V. Fluid Administration Sets, Product Codes D-60HL and DI-60HL should be reported to Smiths Medical Canada, Ltd. or Health Canada at the following addresses:

Sincerely,

original signed by

John Bell, President
Smiths Medical Canada, Ltd.

---

Urgent Recall Notice
Confirmation Return Form for Customers / Distributors

For Level 1^® Normothermic I.V. Fluid Administration Sets,
Product Codes D-60HL AND DI-60HL
Over-Length Issue

Please complete and return this Form by fax 905-477-2144 or by sending an electronic copy via email to chinh.luu@smiths-medical.com.

Check all applicable boxes below:

• YES - I have Level 1^® Normothermic I.V. Fluid Administration Sets, D-60HL and DI-60HL, identified by the Lot Numbers listed above. (Add a list of your Lot Numbers and call Smiths Medical at 905-477-2000 ext. 173 for details on how to return your affected product for replacement.) - Enter total number of your affected Disposable Sets in the table below =
• NO - I do not have any Level 1^® Normothermic I.V. Fluid Administration Sets, D-60HL and DI-60HL, as identified by the Lot Numbers listed above.
• I no longer have any Level 1^® Normothermic I.V. Fluid Administration Sets, D-60HL and DI-60HL, as identified by the Lot Numbers listed above. These products have been transferred to the following location:
• All of my Level 1^® Normothermic I.V. Fluid Administration Sets, D-60HL and DI-60HL, identified by the Lot Numbers listed above, have been consumed.

Printed Name:
Department:
Signature:
Date:
Facility Name:
Facility Adr:

Telephone: (  )
Extension:
Fax: (  )

Table 1

Customer Recall Inventory of Level 1^® Normothermic I.V. Fluid Administration Sets, Product Codes D-60HL AND DI-60HL as Identified by the Lot Numbers

Facility Name:

Lot Number:
Quantity:

Lot Number:
Quantity:

Lot Number:
Quantity:

Lot Number:
Quantity:

For Smiths Medical Use Only

Customer Account No.
RGA No.

• Copy to returns