| Subject: | Cardiovascular Systems, Inc. Announces Voluntary Recall of All Lots of the ViperSheath Sheath Introducer |
| Category: | Food and Drug Administration (FDA)
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| Published: | Tue, 17 Nov 2009 - 02:00 pm |
| Cardiovascular Systems, Inc. (CSI) has announced a voluntary recall of all lots of the ViperSheath Sheath Introducer on behalf of Thomas Medical due to reports about stretching or fracture of the sheath during use. CSI initiated the nationwide recall on November 2, 2009.The ViperSheath Sheath Introducer is a product developed and manufactured by Thomas Medical Products, Inc., and distributed by CSI. It is a long-coil reinforced, kink-resistant catheter sheath that facilitates percutaneous entry... The full article is available to StayAlert subscribers. Click here for a free trial subscription. |
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