WASHINGTON -- The FDA has issued a Class I recall of the Arrow NextStep Antegrade Chronic Hemodialysis Catheter because the product's stylet may break or separate.

The recall affects six lots of the device -- RV1034909, RV1034911, RV1034912, RV1034913, RV1034914, and RV1034915 -- manufactured from April 14, 2011, to May 9, 2011, an FDA statement said.

The products were distributed to healthcare facilities in California, Delaware, Florida, Michigan, North Carolina, and Tennessee.

The catheter is used typically in large veins in a patient's neck to allow long-term access for hemodialysis and apheresis.

Class I recalls affect products with a reasonable chance of causing serious injury or death.

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