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Miles
Km80.5

   

Class I Recall for Arrow International, Inc. (ARRO)'s Arrow NextStep Antegrade Chronic Hemodialysis Catheter


8/4/2011 8:58:45 AM

AUDIENCE: Risk Manager

ISSUE: FDA notified healthcare professionals of a Class I recall of the Arrow NextStep Antegrade Chronic Hemodialysis Catheters, due to reports of breakage and/or separation of the stylet. These products were distributed to medical facilities and physicians in California, Delaware, Florida, Michigan, North Carolina, and Tennessee. The affected products were manufactured between April 14, 2011 and May 9, 2011. See the Recall Notice for a listing of affected product and lot numbers.

BACKGROUND: The Arrow NextStep Antegrade Catheter is indicated for use in adult patients for attaining long-term vascular access for hemodialysis and apheresis. Chronic hemodialysis catheters are typically placed into a large vein in the patient's neck.

RECOMMENDATION: Customers should check their stock, cease use and distribution, and quarantine all affected product. See the Recall Notice for additional information.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the FDA Recall Notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm266526.htm



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