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Class 3 Device Recall Platinum Plus |
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Date Initiated by Firm |
August 25, 2008 |
Date Posted |
October 02, 2008 |
Recall Status1 |
Terminated 3 on December 10, 2011 |
Recall Number |
Z-0030-2009 |
Recall Event ID |
49462 |
510(K)Number |
K945379 K935997
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Product Classification |
Guidewire - Product Code DQX
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Product |
Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches. |
Code Information |
Lot # 11574626 |
Recalling Firm/ Manufacturer |
Boston Scientific Corporation 1 Scimed Pl Maple Grove MN 55311-1565
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For Additional Information Contact |
763-494-1700
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Manufacturer Reason for Recall |
Boston Scientific is initiating a voluntary recall of the Platinum Plus Guidewire (peripheral). BSC has received reports that product may be labeled as a 260 CM long guidewire when the actual packaged device is a 180 CM long guidewire and the product may be labeled as a 180 CM long guidewire when the actual packaged device is a 260 CM long guidewire. There is no expected potential for injury to
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FDA Determined Cause 2 |
Labeling mix-ups |
Action |
A "Boston Scientific Urgent Voluntary Medical Device Recall or Correction - Immediate Action Required" letter dated 8/25/08 was sent to each affected account (To The Hospital Field Action Contact). The letter includes the customer steps for recall, a complete listing of all product batches/lots being recalled, the Reply Verification Tracking Form(s), and a return shipping label. Contact Boston Scientific Corporation at 1-763-494-1700 for assistance. |
Quantity in Commerce |
47 |
Distribution |
USA:
CA
FL
GA
IL
IN
LA
MN
MO
NJ
NV
NY
OH
PA
TN
TX
UT
WA
WI and
WV
OUS: France, Germany, Great Britain, Italy, and the Netherlands. |
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 = DQX and Original Applicant = BOSTON SCIENTIFIC CORP.
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