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U.S. Department of Health and Human Services

Class 1 Device Recall Arrow NextStep Antegrade Chronic Hemodialysis Catheter

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 Class 1 Device Recall Arrow NextStep Antegrade Chronic Hemodialysis Cathetersee related information
Date Initiated by FirmJune 28, 2011
Date PostedJuly 30, 2011
Recall Status1 Terminated 3 on April 16, 2012
Recall NumberZ-2883-2011
Recall Event ID 59212
510(K)NumberK102238 
Product Classification Catheter, hemodialysis, implanted - Product Code MSD
ProductArrow NextStep Antegrade Chronic Hemodialysis Catheter. Product is used for attaining long-term vascular access for hemodialysis and apheresis.
Code Information Product Number CS-15192-IXM, Lot Number RV1034909; Product Number CS-15232-IXM, Lot Number RV1034911; Product Number CS-15272-IXM, Lot Number RV1034912; Product Number CS-15312-IXM, Lot Number RV1034913; Product Number CS-15422-IX, Lot Number RV1034914; and Product Number CS-15502-IX, Lot Number RV1034915. 
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Road
Reading PA 19605
For Additional Information ContactTracy Larish
610-378-0131 Ext. 3835
Manufacturer Reason
for Recall		Firm has received complaints indicating breakage and/or separation of the stylet within the Arrow(R) NextStep(R) Antegrade Catheters.
FDA Determined
Cause 2		Device Design
ActionAn "Urgent Medical Device Recall" letter dated June 28, 2011 was issued 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, call 1-800-233-3187.
Quantity in Commerce41
DistributionUnited States (states of CA, DE, FL, MI, NC, and TN).
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = MSD
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