RUSCH Irrigation Trays - Potential Contamination of Co-Packaged Alcohol Prep Pads - Notice to Hospitals

Starting date:

April 6, 2011

Posting date:

April 13, 2011

Type of communication:

Notice to Hospitals

Subcategory:

Medical Device

Source of recall:

Health Canada

Audience:

Healthcare Professionals

Identification number:

RA-170002514

This is duplicated text of a letter from Teleflex Medical L.P.
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 Rusch Irrigation Trays

April 6, 2011

To: Hospital Chief of Medical Staff

This Recall Notice supersedes Teleflex Medical's Field Corrective Action notice dated and sent March 3, 2011

The Recall Notice dated March 3, 2011 is not posted on the MedEffect Canada Website.

Please distribute to relevant Departments [Surgery, Urology, Emergency Medicine, Paediatrics, Anaesthesia, Geriatrics, Internal Medicine and Nursing, Intensive Care] and post this Notice in your institution.

Subject: Potential contamination of alcohol prep pads co-packaged with RUSCH Irrigation Tray with Piston Catalogue Number 67890 and RUSCH Irrigation Tray with Bulb Catalogue Number 68895

Teleflex Medical Catalogue Number:
67890

Lot Number:
002514, 002519, 004514, 005508, 901526, 902507, 904510, 905501, 906512, 907509, 908502, 908524, 911513

Teleflex Medical Catalogue Number:
68895

Lot Number:
002516, 002520, 003512, 004513, 005510, 005528, 006510, 007513, 901524, 901545, 902519, 903508, 904511, 905502, 907516, 907528, 908518, 912503

These irrigation trays contain alcohol prep pads which are included in the scope of a recall initiated by Triad Group, who supplies the alcohol prep pads. This recall was initiated by Triad Group due to concerns about potential bacterial contamination of the prep pads. If contaminated alcohol prep pads are used, there is a potential for infection to occur.

We are now notifying our customers to take the following actions:

• Please check stock for product within the scope of this recall. Users should cease use and distribution of stock from the affected lot number and quarantine all products from the affected lot number immediately.
• If applicable, please complete the enclosed Recall Acknowledgement Form immediately and fax to 905-943-9001, Customer Service. This will allow us to document the amount of product you have on hand.
• If you have stock from the affected lot number, a Customer Service Representative will contact you with a Return Good Authorization (RGA) Number and will provide instructions for the return of product to Teleflex Medical.

Health Canada has been notified of this action.

If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-800-387-7819.

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 infections or other serious or unexpected adverse incidents for medical devices in patients using Rusch Irrigation Trays should be reported to Teleflex Medical L.P. or Health Canada at the following addresses:

Teleflex Medical L.P.
165 Gibson Drive, Markham, ON L3R 3K7

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).

Sincerely,

original signed by

Hanien Likjono
RAQA Specialist
Teleflex Medical L. P.

This HTML document is not a form. Its purpose is to display the information as found on the form for viewing purposes only. If you wish to use the form, you must use the alternate format below.

[NJS_FILE:6e5a40a6-dfcc-4841-89fd-157b05f7a8d6:9187db8d-7748-4cc2-923e-36dbda8f1f1b]

Recall Acknowledgment Form

Urgent Medical Device Recall - Immediate Attention Requested

Check the appropriate box and fax this form immediately to 905-943-9001, Customer Service

• We have no inventory within the scope of this recall.
• We have the following affected product at our facility and have discontinued use and distribution. We have quarantined the affected product, and will return the following quantities. When the product is received by Teleflex Medical, please credit our account.

Contact Teleflex Medical Customer Service at 1-800-387-7819 or Fax 905-943-9001 for a Return Authorization Number

Catalog Number 67890
Lot Number
Quantity (Each)

Catalog Number 68895
Lot Number
Quantity (Each)

We have received the above product(s) from: (Distributor Name)

(Signature)

(Date)

(Print Name)

(Title)

(Institution Name)

(Telephone Number)

(Street Address)

(Fax Number)

(City, Province, Postal Code)

(Email Address)

Teleflex Medical Use Only

Received by:

Customer Number:

Date:

Return Authorization Number: