Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall

  • 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 3 Device Recall see related information
Date Initiated by Firm May 25, 2004
Date Posted August 10, 2005
Recall Status1 Terminated 3 on February 06, 2006
Recall Number Z-1112-05
Recall Event ID 32271
510(K)Number K963806  
Product Classification Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
Product PASV Central Venous Catheter, 7F, Cat. # CVC702IK, Model # M0001CVC702IK. The 7Fr PASV Central Venous Catheter is a packaged configuration comprised of a silicone Central Venous Catheter with PASV Valve, Guidewire, Syringe, Needle, Tunneler, Scalpel, Sheath/Dilator, and caps. Firm on the label: Boston Scientific*** Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801.
Code Information 934445 exp. 2/28/2007; 942510 exp. 1/31/2007; 938122 exp. 3/31/2007; 935225 exp. 2/28/2007; 933703 exp 1/21/2007; 931401 exp. 12/31/2006; 929657 exp. 12/31/2006; 929435 exp. 12/31/2006.
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
1 Boston Scientific Pl
Natick MA 01760-1536
For Additional Information Contact Marie Peters
508-683-4014
Manufacturer Reason
for Recall		 Kits labeled to contain 0.028" guidewire contain 0.038" guidewire.
FDA Determined
Cause 2		 Other
Action Letters dated May 25, 2004 with instructions to return product to the Quincy, MA location.
Quantity in Commerce 290
Distribution 278 units shipped to 31 consignees throughout the U.S. 12 units shipped to one foreign consignees located in the UK.
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.
-
-