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Health professional risk communication

Pre-Attached LTA Kit 4% Lidocaine Hydrochloride Topical Solution USP - Recall due to Cannula Breakage - Notice to Hospitals

Starting date:
August 1, 2014
Posting date:
August 1, 2014
Type of communication:
Notice to Hospitals
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Quality, Important Safety Information
Audience:
Healthcare Professionals
Identification number:
RA-40905

This is a duplicated text of a letter from Hospira Healthcare Corporation. 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 Pre-Attached LTA Kit 4% Lidocaine Hydrochloride Topical Solution USP

August 1, 2014   

Dear Healthcare Professional,

Please distribute to the relevant Departments (Surgery, Emergency Medicine, Pharmacy, Paediatrics, Anaesthesia, Geriatrics, Internal Medicine, Nursing, Intensive Care, ENT, Respirology, Surgical Day Care Units, Clinics, Dentistry and/or other Departments as required), other involved professional staff, and post this Notice in all relevant areas of your institution.

Subject: Recall of Hospira Pre-Attached LTATM Kit 4% Lidocaine Hydrochloride Topical Solution USP, (DIN 00295531), lots 23303R1 and 36200R1,  due to cannula breakage

Hospira Healthcare Corporation, in consultation with Health Canada, has initiated an urgent product recall for Hospira Pre-Attached LTA Kit 4% Lidocaine Hydrochloride Topical Solution USP (two lots: lot 23303R1 and lot 36200R1) due to potential for cannula breakage especially when manipulated prior to insertion into patients’ airways, which can result in serious patient harm. Hospira has decided to discontinue distributing this product in Canada.

Globally there have been 19 reports of cannula breakage including one report in Canada.

  • There is potential for serious patient harm if breakage of the cannula occurs during insertion into patients’ airways. Such harm includes retention of the distal fragment in the patient’s airway, need for intervention to remove the foreign body, airway obstruction and respiratory compromise.
  • Two (2) lots of Pre-Attached LTATM Kit 4% Lidocaine Hydrochloride Topical Solution USP are being recalled and should NOT be used.
  • Healthcare Professionals are advised to check their inventory, quarantine any affected product and return to Hospira Healthcare Corporation.

The LTA Kit 4% Lidocaine Hydrochloride Topical Solution USP is used for producing topical anaesthesia of the interior of the larynx and trachea. Each kit consists of a sterile curved plastic cannula with attached vial injector and a single-use vial prefilled with 4 mL of sterile aqueous solution of Lidocaine Hydrochloride Topical Solution, USP.

To return your quarantined product, please contact Hospira Healthcare Corporation at: 1-866-488-6088 Option 3, contacthospira.ca@hospira.com. A Return Goods Authorization (RGA) number will be issued to facilitate the return of your products.

The product impacted is:

Product DIN List Number Lot Expiration
Pre-Attached LTATM Kit
4% Lidocaine Hydrochloride Topical Solution USP
00295531 04698880 23303R1 November 1, 2014
36200R1 December 1, 2015

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-market adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any cases of serious or unexpected adverse reactions in patients receiving Pre-Attached LTATM Kit 4% Lidocaine Hydrochloride Topical Solution USP should continue to be reported to Hospira Healthcare Corporation or Health Canada:

Hospira Healthcare Corporation
1111 Dr.-Fredrerik-Philips, Suite 600
Saint-Laurent (Quebec) H4M 2X6
To report an Adverse Reaction, consumers and health professionals may call toll free:
Tel: 1-866-488-6088 Option 6
Fax: 1-877-906-0208
Email: ProductcomplaintsCA@hospira.com

To correct your mailing address or fax number, contact Hospira Healthcare Corporation.

You can report any suspected adverse reactions associated with the use of health products to Health Canada by:

  • Calling toll-free at 1-866-234-2345, or
     
  • Visiting MedEffect Canada’s Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

For other health product inquiries related to this communication, contact Health Canada at:
Health and Product and Food Branch Inspectorate
E-mail: DCVIU_UVCEM@hc-sc.gc.ca
Telephone: 1-800-267-9675
Fax: 1-613-946-5636

Sincerely,

Original signed by

Rania Al-Ammar
Regional Director, Commercial Quality
Hospira Healthcare Corporation