510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-1760-2024Class II

DURAFLOW 2, 24CM STRAIGHT BASIC KIT -Indicated for use in attaining Long-Term vascular access for...

Boston Scientific Corporation / initiated 2024-03-18 / Open, Classified
FDA source (opens on fda.gov)

Angiodynamics, Inc. began a recall of DURAFLOW 2, 24CM STRAIGHT BASIC KIT -Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012015 on . FDA classified it as Class II and gives the reason as "Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure". As of , the recall status on record is Open, Classified.

Recall record

Recall number
Z-1760-2024
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Boston Scientific Corporation
Product
DURAFLOW 2, 24CM STRAIGHT BASIC KIT -Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012015
Product code
MSD Catheter, Hemodialysis, Implanted
Reason for recall
Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
FDA root cause
Under Investigation by firm
Action
Angiodynamics issued Recall Notifications Packages via Federal Express to 1 Domestic Consignee on 2024-03-18 . Letter states reason for recall, health risk and action to take: IMMEDIATELY o Locate the affected product in your Inventory, cease any and all distribution segregate in a secure location pending return. o Forward a copy of this recall notification to any locations to which you have distributed affected product. 2. Complete and return the Reply Verification Tracking Form. " Promptly complete, sign, and return the enclosed Reply Verification Tracking Form (even if you do not have any product to return), following the directions on this page and the Reply Verification Tracking Form. Email Reply Verification Tracking Form (preferred): [email protected] Fax Reply Verification Tracking Form: Attn: Hemodialysis Catheter Kits with Tri-Ball Tunneller Fax number 1-855-273-0519 " Call AngioDynamics Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday Friday: Eastern Standard Time) to obtain a replacement or credit for your returned product. Package any product that is being returned in an appropriate shipping box. " Write the RMA number on the RMA label (provided on the Recall Verification Tracking Form) and affix the label to the outside of the shipping box. " Seal the box and return via your preferred carrier to: AngioDynamics, Inc. 24 Native Drive Queensbury, NY 12804 Attn: Hemodialysis Catheter Kits with Tri-Ball Tunneller
Quantity in commerce
455 units
Distribution
VA
Product codes and lots
UDI-DI: 25051684014738 Lot Numbers: 5807192, 5807197

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1760-2024
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1760-2024Class IIOngoingVoluntary: Firm initiated
Z-1761-2024Class IIOngoingVoluntary: Firm initiated
Z-1762-2024Class IIOngoingVoluntary: Firm initiated
Z-1763-2024Class IIOngoingVoluntary: Firm initiated
Z-1764-2024Class IIOngoingVoluntary: Firm initiated
Z-1765-2024Class IIOngoingVoluntary: Firm initiated
Z-1766-2024Class IIOngoingVoluntary: Firm initiated
Z-1767-2024Class IIOngoingVoluntary: Firm initiated
Z-1768-2024Class IIOngoingVoluntary: Firm initiated
Z-1769-2024Class IIOngoingVoluntary: Firm initiated
Z-1770-2024Class IIOngoingVoluntary: Firm initiated
Z-1771-2024Class IIOngoingVoluntary: Firm initiated
Z-1772-2024Class IIOngoingVoluntary: Firm initiated
Z-1773-2024Class IIOngoingVoluntary: Firm initiated
Z-1774-2024Class IIOngoingVoluntary: Firm initiated