Arrow NextStep Antegrade Chronic Hemodialysis Catheter. Product is used for attaining long-term vascular access for hemodialysis and apheresis.
FDA Recall Z-2883-2011 · Posted 2011-07-30
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Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeMSD
Date Initiated2011-06-28
Date Terminated2012-04-16
Product Quantity41
Reason for Recall
Firm has received complaints indicating breakage and/or separation of the stylet within the Arrow(R) NextStep(R) Antegrade Catheters.
Firm Action
An "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.
Root Cause
Device Design
Distribution Pattern
United States (states of CA, DE, FL, MI, NC, and TN).
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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