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U.S. Department of Health and Human Services

Class 2 Device Recall Safe Sheath ULTRALITE 8F Safe Sheath Introducer.

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 Class 2 Recall
Safe Sheath ULTRALITE 8F Safe Sheath Introducer.
see related information
Date Posted October 13, 2011
Recall Status1 Terminated on March 07, 2012
Recall Number Z-0055-2012
Recall Event ID 59526
Premarket Notification
510(K) Number
K073100 
Product Classification Introducer, Catheter - Product Code DYB
Product 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.
Code Information Catalog number: V18, Lot numbers D1-01664 and D101799
Recalling Firm/
Manufacturer
Angiodynamics, INC
1 Horizon Way
Manchester, Georgia 31816-1749
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact S. Michael Sharp, PhD
518-795-1123
Manufacturer Reason
for Recall
The product may contain an incorrect size catheter and introducer.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components
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.
Quantity in Commerce 1095 total units
Distribution (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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DYB and Original Applicant = Oscor Inc.
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