Arrow International Inc.â€¨is recalling certain lots of its NextStep Antegrade Chronic Hemodialysis Catheters, the U.S. Food and Drug Administration (FDA) has announced. The recall has been deemed a Class I by the agency, which is its most serious designation and involves situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Arrow International Inc., which is located atâ€¨2400 Bernville Road,â€¨Reading, Pennsylvania, 19605, received complaints 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. Chronic hemodialysis catheters are typically placed into a large vein in the patient’s neck.
The recall of Arrow NextStep Antegrade Chronic Hemodialysis Catheters was initiated on June 28, 2011 and involves products manufactured between April 14, 2011 and May 9, 2011 that were distributed to medical facilities and physicians in California, Delaware, Florida, Michigan, North Carolina, and Tennessee. The impacted products bear the following product and lot numbers:
â€¢ Product Number: CS-15192-IXM; Lot Number: RV1034909
â€¢ Product Number: CS-15232-IXM; Lot Number: RV1034911
â€¢ Product Number: CS-15272-IXM; Lot Number: RV1034912
â€¢ Product Number: CS-15312-IXM; Lot Number: RV1034913
â€¢ Product Number: CS-15422-IX; Lot Number: RV1034914
â€¢ Product Number: CS-15502-IX; Lot Number: RV1034915
Arrow International Inc. mailed an “Urgent Medical Device Recall” letter, dated June 28, 2011, to consignees. The letter requested that customers check their stock, cease use and distribution, and quarantine all affected product. Consignees were further directed to complete the “Recall Acknowledgement & Stock Status Form” and to return the form to their sales representative, and return the affected product, as instructed, on the letter.
Arrow International Customer Service can be reached, toll-free, at 1.800.233.3187.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDAâ€™s Safety Information and MedWatch Adverse Event Reporting Program either online, by regular mail or by FAX. Information on the program is available at: http://www.fda.gov/Safety/MedWatch/default.htm.