• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Silicone PICC catheter with PASV Valve.

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  Class 2 Device Recall Silicone PICC catheter with PASV Valve. see related information
Date Initiated by Firm March 05, 2004
Date Posted July 28, 2005
Recall Status1 Terminated 3 on February 06, 2006
Recall Number Z-1052-05
Recall Event ID 31811
510(K)Number K963097  
Product Classification Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
Product PICC Custom Kit GENESIS MEDICAL CENTER, 4.5F Dual Lumen , Catalog #60M120522. UPN M00160M1205221. Firm on label: Boston Scientific Corporation, NAMIC Technology Center, 10 Glens Falls Technical Park, Glens Falls, NY
Code Information 898659, 899145
Recalling Firm/
Boston Scientific Corporation
1 Boston Scientific Pl
Natick MA 01760-1536
For Additional Information Contact Marie Peters
Manufacturer Reason
for Recall
Lumens may have incorrect lumen size marked on them.
FDA Determined
Cause 2
Action Letters dated March 5, 2004 with instructions to return product to Boston Scientific.
Quantity in Commerce 44 kits
Distribution Nationwide. Medical facilities in CA, GA, IA, IL, ME, MI, MO, NJ, OH, TN TX, UT, WI,
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = LJS and Original Applicant = BMW MEDICAL, INC.