| Subject: | Class I Recall of Four Lots of POWERSAIL® Coronary Dilatation Catheters |
| Category: | Food and Drug Administration (FDA)
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| Published: | Thu, 30 Jul 2009 - 02:00 pm |
| Abbott has conducted a voluntary recall of three lots of POWERSAIL® Coronary Dilatation Catheters from United States distribution and one lot from international distribution as a result of four complaints (one from each lot) that the distal shaft of the catheter exhibited damage. While the issue could be detected and avoided during the preparation for use of the product, it may cause a leak of contrast material during use, which could lead to catheter functional failures and clinical... The full article is available to StayAlert subscribers. Click here for a free trial subscription. |
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