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Class 2 Device Recall Silicone PICC catheter with PASV Valve. |
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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
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Product Classification |
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
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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/ Manufacturer |
Boston Scientific Corporation 1 Boston Scientific Pl Natick MA 01760-1536
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For Additional Information Contact |
Marie Peters 508-652-5875
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Manufacturer Reason for Recall |
Lumens may have incorrect lumen size marked on them.
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FDA Determined Cause 2 |
Other |
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
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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.
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510(K) Database |
510(K)s with Product Code = LJS and Original Applicant = BMW MEDICAL, INC.
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