| Subject: | Medtronic Initiates Voluntary Field Actions for Selected Heparin-Coated Products Used During Cardiopulmonary Bypass |
| Category: | Food and Drug Administration (FDA)
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| Published: | Thu, 15 May 2008 - 10:00 am |
| Medtronic, Inc. has announced that it is initiating a voluntary and precautionary recall of selected products featuring the Carmeda BioActive surface. The affected devices are disposable products used during cardiopulmonary bypass (CPB) for heart surgeries. Affected products include blood oxygenators, reservoirs, pumps, cannulae, and tubing packs. This action is being taken subsequent to the FDA's April 8, 2008 recommendation to device manufacturers that heparin supplies be checked with... The full article is available to StayAlert subscribers. Click here for a free trial subscription. |
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