Important Safety Alerts

Important Safety Alerts

FDA Class I Recall: Arrow NextStep Antegrade Chronic Hemodialysis Catheter manufactured between April 14, 2011 and May 9, 2011

05 Aug 2011

It has come to our attention that The U.S. Food and Drug Administration (FDA) has issued a Class I Recall to healthcare professionals followed by complaints received by the manufacturer indicating breakage and/or separation of the stylet within the Arrow NextStep Antegrade Catheters.

The Arrow NextStep Antegrade Catheter is indicated for use in adult patients for attaining long-term vascular access for hemodialysis and apheresis.

Affected models include:

Caption: Affected models
Model No. Lot No.
CS-15192-IXM RV1034909
CS-15232-IXM RV1034911
CS-15272-IXM RV1034912
CS-15312-IXM RV1034913
CS-15422-IX RV1034914
CS-15502-IX RV1034915

According to the supplier, the affected product was NOT distributed in Hong Kong. If you happen to have the affected product in hand, you are advised to contact your supplier for necessary actions.

For details, please visit the following FDA website: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm266463.htm

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