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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 FirmMarch 05, 2004
Date PostedJuly 28, 2005
Recall Status1 Terminated 3 on February 06, 2006
Recall NumberZ-1052-05
Recall Event ID 31811
510(K)NumberK963097 
Product Classification Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
ProductPICC 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
For Additional Information ContactMarie Peters
508-652-5875
Manufacturer Reason
for Recall
Lumens may have incorrect lumen size marked on them.
FDA Determined
Cause 2
Other
ActionLetters dated March 5, 2004 with instructions to return product to Boston Scientific.
Quantity in Commerce44 kits
DistributionNationwide. Medical facilities in CA, GA, IA, IL, ME, MI, MO, NJ, OH, TN TX, UT, WI,
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LJS
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