8F Safe Sheath Introducer, Catalog number: V18; AngioDynamics, INC. The Valved Introducer sheath is utilized to surgically place the catheter during the port implantation procedure.
FDA Recall Z-0055-2012 · Posted 2011-10-13
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Recalling FirmAngiodynamics, INC
Recall StatusTerminated
Product CodeDYB
Date Initiated2011-08-01
Date Terminated2012-03-07
Product Quantity1095 total units
Reason for Recall
The product may contain an incorrect size catheter and introducer.
Firm Action
AngioDynamics, Inc contacted affected customers initially via telephone and a follow up "Notification of Medical Device Correction" letter was sent dated August 1, 2011.
The letter informed them of the problem and provided instructions. Customers were instructed to utilize the 8F Introducer Sheath provided within the 8F Smart Port CT Implantable Port during port implantation. The 8F Valved Sheath (V18) may continue to be utilized during the placement of the 7.5F Smart Port Implantable Port (for example: CT75STSD; CT75STSD-NF).
For question on this recall contact AngioDynamics, Inc at (800) 772-6446.
Root Cause
Device Design
Distribution Pattern
(USA) Nationwide distribution including the states of CA, FL, GA, IA, IL, IN, KY, MD, MI, MO, NC, NE, NJ, NY, OH, OK, OR, TN, UT, WA and WI.
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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