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Recall Notice, Portex Uncuffed Pediatric-Sized Tracheal Tubes - For Health Professionals

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(PDF Version - 56 K)

Contact: Marketed Health Products Directorate (MHPD)

Health Canada Endorsed Important Safety Information on Portex Uncuffed Pediatric Sized Tracheal Tubes

September 15, 2009

Subject:  Recall Notice, Portex^® Uncuffed Pediatric Sized Tracheal Tubes

Dear Health Care Professional,

Smiths Medical is performing a voluntary Urgent Medical Device Recall regarding Portex^® Uncuffed Pediatric Sized Tracheal Tubes. Smiths Medical has expanded its original Urgent Field Safety Notice, dated August 21, 2009, to include additional Product Codes, expand the manufacture date timeframe and to take this recall action.

Smiths Medical has become aware that variability in the manufacturing process for Portex^® Uncuffed Pediatric Sized Tracheal Tubes has resulted in a small number of tubes having an internal diameter slightly smaller than indicated on the labeling which may create the potential for clinicians to experience difficulty passing through or withdrawing the suction catheter. The health consequences that may result from use of the defective device include the inability to remove secretions from the device and from the patient's airway, which may result in partial or complete obstruction of the airway and an inability to ventilate the patient. Also, this defect may increase airway resistance and compromise the ability to ventilate the patient. There is a reasonable probability of serious injury and/ or death. To date, Smiths Medical has not received any reports of death or permanent injury related to this issue.

The products affected by this recall action have the following Product Codes and are labeled with a manufacture date prior to September 2009:

Action to be Taken by the User:

Subject to this Urgent Medical Device Recall, Smiths Medical is requiring its customers to return all unused Tracheal Tubes, within the expiration date, listed above.

• Review your inventory and segregate any unused product manufactured before September 2009 and within its expiration date.
• Complete and return the attached Confirmation Form by fax to 905-477-2144. You will then be provided with directions on how to return unused affected product.
• If you or your company has distributed these affected Tracheal Tubes to other persons or facilities, please promptly forward the recipients a copy of this Recall Notice.

Some of the following hyperlinks are to sites of organizations or other entities that are not subject to the Official Languages Act. The material found there is therefore in the language(s) used by the sites in question.

If a Tracheal Tube is currently in use with a patient, there is no evidence to suggest that immediate removal of the Tracheal Tube is necessary. If suctioning of a Tracheal Tube currently in use is required, then please follow the recommendations for suction catheter sizes on the Guidance Chart (PDF Version 80.47 K). Clinicians who choose to use larger than recommended suction catheters should base this decision on sound clinical judgment and with caution to assure the suction catheter readily passes through and can be readily withdrawn from the Tracheal Tube.

Replacement inventory of some Product Codes will become available the week of September 28, with additional codes added weekly.

For questions regarding this Urgent Recall Notice, please contact Melissa Lake, Regulatory Affairs, Smiths Medical Canada Ltd., at 905-477-2000 ext 135; via fax at 905-477-2144.

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Attachment: Confirmation Form

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 adverse incidents in patients using Portex^® Uncuffed Pediatric Sized Tracheal Tubes should be reported to Smiths Medical Canada Ltd or Health Canada at the following addresses:

(PDF Version - 56 K)

SMITHS MEDICAL CANADA LTD.

URGENT: CUSTOMER REPLY CONFIRMATION FORM

Complete and Fax Immediately to:

Fax No.:  905-477-2144, or by e-mail:
Smiths Medical Canada Ltd. RA Department
Attention:  Regulatory Affairs

Please fill in regardless of inventory status:

Check One:

• I DO NOT have affected Tracheal Tubes remaining. All have been used or discarded.
• I DO have unused inventory of affected Tracheal Tubes, within its expiration date, which I will return for replacement or credit. (Please provide Product Code and Lot No. details on the second page of this Customer Reply Confirmation Form)

Printed Name:  
Department:  
Signature:  
Date:  
Facility Name:  
Facility Address:
(Street)
(City)
(Province/Postal)
Phone Number
Ext :
Fax Number:
E-Mail Address

Questions should be directed to Melissa Lake at 905-477-2000 ext 135.

For Smiths Medical Use Only

Customer Account No.
RGA #
Copy to Returns

RECALL INVENTORY OF PORTEX^® UNCUFFED PEDIATRIC-SIZED TRACHEAL TUBES, SIZES 2.5, 3.0, AND 3.5 mm

Facility Name:

Returning Product For
CREDIT