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U.S. Department of Health and Human Services

Class 2 Device Recall Silicone PICC catheter with PASV Valve

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  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-1051-05
Recall Event ID 31811
510(K)Number K963097  
Product Classification Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
Product PASV PICC Catheter - 4.5 Fr Dual Lumen, Catalog #PIC402CKMS, Material Number M001PIC402CKMSO. Responsible firm on label: Boston Scientific *** Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801 USA
Code Information 925620
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
1 Boston Scientific Pl
Natick MA 01760-1536
For Additional Information Contact Marie Peters
508-652-5875
Manufacturer Reason
for Recall		 Lumens may have incorrect lumen size marked on them.
FDA Determined
Cause 2		 Other
Action Letters dated March 5, 2004 with instructions to return product to Boston Scientific.
Quantity in Commerce 25 units
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.
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