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:
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