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Health professional risk communication

Important Safety Information on PediCap Pediatric End-Tidal CO2 Detectors - Notice to Hospitals

Starting date:
September 11, 2009
Posting date:
September 22, 2009
Type of communication:
Notice to Hospitals
Subcategory:
Medical Device, Affects children, pregnant or breast feeding women
Source of recall:
Health Canada
Audience:
Healthcare Professionals
Identification number:
RA-170002088

This is duplicated text of a letter from Tyco Healthcare Canada (Covidien).
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 PediCap Pediatric End-Tidal CO2 Detectors

September 11, 2009

Subject: Urgent Medical Device Recall for PediCap End-Tidal CO2 Detectors

Dear Healthcare Professional,

We are informing you of an urgent voluntary medical device recall regarding the PediCap End-Tidal CO2 Detector (PediCap and PediCap 6).

We have received a customer report in which they experienced difficulty manually ventilating an intubated patient through the PediCap. While we continue to investigate, we believe that a recent modification to the PediCap End-Tidal CO2 Detector may result in increased resistance to airflow through the PediCap. This could result in ineffective ventilation of the patient and/or inadequate detection of CO2 levels, so that the indicator paper will not change color.

Although we have received no reports of patient injury, we have determined that all PediCap and PediCap 6 End-Tidal CO2 Detectors from the lots listed below must be returned. We are requesting your assistance in conducting this activity. Please review your inventory and segregate any product with the affected lot numbers and return affected product according to the directions below.

The recall applies to the following 80 lot numbers.

8294199 8301112 8301113 8315189 8315190 8319262 8319263 8322181 8322182 8326251
8326252 8326253 8326254 8329072 8329073 8330001 8333183 8350018 8350019 8354221
8354224 8357021 8357022 8361153 9005011 9005012 9012058 9012059 9026042 9026043 
9033128 9033129 9040067 9040068 9047127 9047128 9054110 9054111 9061066 9061067 
9065209 9068061 9068062 9072281 9075059 9075060 9079160 9082376 9082377 9086312
9089126 9089127 9103038 9103039 9110481 9110482 9117039 9117040 9124134 9124135
9131188 9131189 9138084 9138085 9138226 9145088 9145089 9152238 9152239 9159128 
9159129 9170191 9170192 9170197 9176471 9176477 9184145 9191233 9191234 9204128

Should any recalled product be found, please remove it from inventory and contact Customer Service to arrange for return and credit (1-866-411-4567).

Please return the attached "Customer Response Form" to our Regulatory Affairs Department even if you have none of the products in stock at this time. Your response is vital to our ability to monitor the effectiveness of this voluntary recall.

If you are a distributor, we request that you notify your accounts of this letter and maintain their responses on file.

Please be assured that we are working expeditiously to address this issue in future production and we are aware that this may create supply challenges for your facility. We sincerely apologize for any inconvenience this may cause and appreciate your prompt attention to this matter.

This action is being taken with the knowledge of the relevant regulatory authorities. If you have any questions, please contact the undersigned or your local Tyco Healthcare Sales Representative.

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 serious specific adverse incident or other serious adverse incidents in patients using PediCap End-Tidal CO2 Detectors should be reported to Tyco Healthcare Canada or Health Canada at the following addresses:

Tyco Healthcare Canada (Covidien)
7300 Trans Canada Highway,
Pointe Claire, Quebec, H9R 1C7
Telephone: 1-877-664-8926

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 inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate (MHPD)
E-mail: MHPD_DSPC@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738

original signed by

Joseph Di Marzo
Director, Regulatory Affairs and Quality Assurance

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CUSTOMER RESPONSE FORM
PediCap® End-Tidal CO2 Detector Recall

The following information must be completed and faxed to:
Tyco Healthcare Canada,
Dawn Boyce - Product Monitoring
Fax: 514-695-2379

Please indicate as applicable:

  • As indicated in the table below, we have no affected product in stock.
  • We have affected product in stock as indicated on the below table:
    • We have discontinued use of the product and will return the goods to Tyco Healthcare facility.
    • We understand that upon receipt of this Response Form we have contacted Tyco Healthcare Customer Service to arrange for credit and product return at 1-866-411-4567.
Quantity Case or Each Part Number Lot Number
     
     
     
  • Hospital Name:
  • Address:
  • City, Province:
  • Printed Name:
  • Title / Department:
  • Signature:
  • Date:
  • Phone Number: