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U.S. Department of Health and Human Services

Medical Devices

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Thomas Medical Products Inc., Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport

Recall Class: Class I

Date Recall Initiated: December 17, 2009

Product: Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport

To find all the affected lot and catalog numbers, see the press release below under Useful Links.

This product was manufactured and distributed from December 1, 2005 through December 1, 2009.

Use: Sheaths are tube-like devices placed into blood vessels. Pacing or defibrillator wires and catheters are placed through sheaths to easily insert them into blood vessels.

Recalling Firm:

Thomas Medical Products, Inc.
65 Great Valley Parkway
Malvern, Pennsylvania 19355-1302

Distributor:

Pressure Products, Inc.
1861 N. Gaffey Street, Suite B
San Pedro, CA 90731

Reason for Recall:

The sheath tip may break off and separate while the sheath is inside a blood vessel. If this occurs, the sheath tip could move through the blood vessel into organs such as the lungs and heart or, less commonly, into arteries. From there, the broken tip could cause a blockage anywhere, including the brain or heart, leading to permanent injury, such as a stroke or heart attack, or even death.

Public Contact:

Customers with questions may contact Thomas Medical Products at 1-866-466-3303, Monday through Friday, from 8:30 AM to 5:00 PM, Eastern Time or by email at info@thomas-medical.com

FDA District: Philadelphia

FDA Comments:

On December 23, 2009, Thomas Medical Products sent an email message to Pressure Products asking them to stop distributing these sheaths and to return all unused devices affected by this recall. Thomas Medical Products also asked the distributor to recall the products from all their customers.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

Useful Links: