Class I Recall of Arrow NextStep Hemodialysis Catheter

Megan Brooks

Disclosures

August 05, 2011

August 5, 2011 — The US Food and Drug Administration (FDA) has notified healthcare professionals of a class I recall of the Arrow NextStep Antegrade Chronic Hemodialysis Catheters. The recall was prompted by reports of breakage and/or separation of the stylet.

The recalled products were distributed to medical facilities and physicians in California, Delaware, Florida, Michigan, North Carolina, and Tennessee. They were manufactured between April 14, 2011, and May 9, 2011. The product numbers and lot numbers are as follows:

Product Number Lot Number
CS-15192-IXM RV1034909
CS-15232-IXM RV1034911
CS-15272-IXM RV1034912
CS-15312-IXM RV1034913
CS-15422-IX RV1034914
CS-15502-IX RV1034915

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

Arrow International, Inc, mailed an "Urgent Medical Device Recall" letter, dated June 28, 2011, to purchasers, requesting that they check their stock, cease use and distribution, and quarantine all affected product.

Class I recalls are "the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death," according to the FDA.

The company has asked purchasers to complete the "Recall Acknowledgement & Stock Status Form," return it to their sales representative, and return affected product as instructed in the letter.

For questions or concerns about the recall, contact the company at 1-800-233-3187.

More information about the recall is available on the FDA Web site.

Adverse events related to the product can also be communicated to MedWatch by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.

Comments

3090D553-9492-4563-8681-AD288FA52ACE
Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.
Post as:

processing....