Level 1 Normothermic I.V. Fluid Administration Sets equipped with F-50 Gas Vent Filter Assembly - Market Withdrawal - Notice to Hospitals

Starting date:

June 21, 2011

Posting date:

July 21, 2011

Type of communication:

Notice to Hospitals

Subcategory:

Medical Device

Source of recall:

Health Canada

Audience:

Healthcare Professionals

Identification number:

RA-170002454

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 about Health Canada advisories

Notice to Hospitals
Health Canada Endorsed Important Safety Information on Level 1 Normothermic I.V. Fluid Administration Sets equipped with the F-50 Gas Vent Filter Assembly (Product Codes: F-50, DI-65HL, DI-75, DI-150, and DI-350)

June 21, 2011

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: Market Withdrawal of Level 1 Normothermic I.V. Fluid Administration Sets equipped with the F-50 Gas Vent Filter Assembly. Product Codes: F-50, DI-65HL, DI-75, DI-150, and DI-350, All Lot Numbers.

Smiths Medical has made the decision to voluntarily withdraw all lot numbers of Level 1 Normothermic I.V. Fluid Administration Sets equipped with the F-50 Gas Vent Filter Assembly, Product Codes: F-50, DI-65HL, DI-75, DI-150 and DI-350 ("F-50 Disposables") from the market and temporarily suspend all sales of these products.

Smiths Medical is conducting this voluntary market withdrawal because of complaints of kinking of the tubing and leaking at the F-50 Gas Vent Filter Assembly ("GVFA"). In some cases, kinking in the tubing or leaking of the F-50 GVFA can cause a decrease in fluid flow rate. A reduction in flow rate may lead to a delay of therapy, which could result in patient injury or death. None of the reported complaints has resulted in patient injury or death.

This Recall Notice applies to all F-50 Disposable Product Codes and all Lot Numbers.

The original Level 1 Normothermic I.V. Fluid Administration Sets that are not equipped with the F-50 Gas Vent Filter Assembly are available as replacements:

Product Codes with the F-50 GVFA / Replacement Product Codes

• F-50 / F-10 or F-30
• DI-65HL / DI-60HL
• DI-75 / DI-50
• DI-150 / DI-100
• DI-350 / DI-300

Action to be taken by the User

• Smiths Medical is requiring its customers to return all unused F-50 Disposables.
• Inspect your inventory and quarantine all unused F-50 Disposables.
• Complete and return the attached Confirmation Form provided below by Fax to 905-477-2144 or by email to melissa.lake@smiths-medical.com.
• Upon receipt of your Confirmation Form, Smiths Medical will contact you to discuss replacement or credit for your unused F-50 Disposables.
• It is important to note that if a Level 1 H-1200 Fast Flow Fluid Warmer equipped with the H-30, H-31 A, or the H-31 B air detector is powered off when the Air Detector is in an active alarm state, the Air Detector/Clamp will open and the Air Detector will become disabled. This could allow any air within the Patient Line to be delivered to the patient, resulting in serious injury or death.

In an emergency situation, sound clinical judgment should be applied to determine whether using a F-50 Disposable for the benefit of the fast flow fluid delivery outweighs the potential risk associated with use of the F-50 Disposable. The leaking and kinking that has been observed has not been to the extent that it significantly impacts fluid flow. In the event that a clinician makes the decision to use a F-50 Disposable, they should closely monitor flow rates during use. If a diminished flow rate is observed as a result of a kink in the tubing, the clinician can manually hold the tubing to support the tubing and establish a more normal flow.

Action to be taken by the Distributor

• Smiths Medical is requiring its customers to return all unused F-50 Disposables.
• Immediately stop distributing and quarantine all inventory of F-50 Disposables.
• Identify any customers in receipt of the devices covered by this Urgent Recall Notice.
• Send a copy of this Notice, with attachments, to those customers identified as receiving F-50 Disposables.
• Contact Smiths Medical at 905-477-2000, ext. 135, to confirm the mailings have been sent.
• Complete and return the Confirmation Form provided below by Fax to 905-477-2144 or by email to melissa.lake@smiths-medical.com.

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: F-50, DI-65HL, DI-75, DI-150 and DI-350, should be reported to Smiths Medical Canada Ltd. or Health Canada at the following addresses:

Smiths Medical Canada Ltd.
301 Gough Road
Markham, Ontario L3R 4Y8
Canada

Any suspected adverse incident 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 medical device inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate
E-mail: MHPD_DPSC@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738

To change your mailing address or fax number, contact the Market Authorization Holder (Industry).

original signed by

John Bell,
President
Smiths Medical Canada Ltd.

Urgent recall notice
Confirmation form for customers/distributors

For Level 1 Normothermic I.V. Fluid Administration Sets that are equipped with the F-50 Gas Vent Filter Assembly (GVFA) (Product Codes: F-50, DI-65HL, DI-75, DI-150, DI-350)
Kinking Tubing/ Leaking GVFA Issue

Please complete and return this Form by Fax to 905-477-2144 or by sending an electronic copy via Email to melissa.lake@smiths-medical.com

Check the applicable boxes below:

___I DO NOT have any F-50 Disposables in inventory. All have been used or discarded.

___I DO have unused inventory of F-50 Disposables, which I will return for replacement with Non F-50 Disposables or credit. Please provide Product Reorder details in the table provided below. Smiths Medical will contact you to arrange for product return and to discuss your fast flow warming options.

___I no longer have any F-50 Disposables. These F-50 Disposables have been transferred to the following location: []

• Printed Name:
• Department:
• Signature:
• Date:
• Facility Name:
• Facility Address:
• Shipping Address:
• Phone Number (with Extension):
• E-mail:

CUSTOMER RECALL Inventory of Level 1 Normothermic I.V. Fluid Administration Sets that are equipped with the F-50 Gas Vent Filter Assembly (Product Codes: F-50, DI-65HL, DI-75, DI-150, DI-350)

Facility Name:

Returning Product For: ___ REPLACEMENTS ___ CREDIT

• Reorder Code: [ ] Quantity: [ ] Please check if Qty is by: ___box of 10 or___each
• Reorder Code: [ ] Quantity: [ ] Please check if Qty is by: ___box of 10 or___each
• Reorder Code: [ ] Quantity: [ ] Please check if Qty is by: ___box of 10 or___each
• Reorder Code: [ ] Quantity: [ ] Please check if Qty is by: ___box of 10 or___each
• Reorder Code: [ ] Quantity: [ ] Please check if Qty is by: ___box of 10 or___each
• Reorder Code: [ ] Quantity: [ ] Please check if Qty is by: ___box of 10 or___each
• Reorder Code: [ ] Quantity: [ ] Please check if Qty is by: ___box of 10 or___each