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Class I Medical Device Recall: Arrow International, Inc. Arrow NextStep Antegrade Chronic Hemodialysis Catheter

Posted Aug 03 2011 12:00am

Recall Class: Class I

Date Recall Initiated: June 28, 2011

Product: Arrow NextStep Antegrade Chronic Hemodialysis Catheter

The affected products were manufactured between April 14, 2011 and May 9, 2011:

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

These products were distributed to medical facilities and physicians in California, Delaware, Florida, Michigan, North Carolina, and Tennessee.

Use: 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.

Recalling Firm:
Arrow International Inc.
2400 Bernville Road
Reading, Pennsylvania 19605

Reason for Recall: Arrow International Inc. received complaints indicating breakage and/or separation of the stylet within the Arrow NextStep Antegrade Catheters.

Public Contact: If you have questions about this recall, contact Arrow International Inc. Customer Service at 1-800-233-3187.

FDA District: Philadelphia

FDA Comments:
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," return the form to their sales representative, and return affected product as instructed on the letter. For questions or concerns, contact Arrow International Inc. Customer Service at 1-800-233-3187.

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.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA’s Safety Information and MedWatch Adverse Event Reporting Program either online, by regular mail or by FAX.

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