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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmJune 16, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on February 11, 2005
Recall NumberZ-1105-04
Recall Event ID 29476
Product Classification Dilator, Vessel, For Percutaneous Catheterization - Product Code DRE
ProductBoston Scientific/MEDI-TECH brand Fascial Dilator, 10 FR (3.3 mm), sterile, single use only, model M001482501, REF/Catalog No. 48-250.
Code Information Lot 6015888.
FEI Number 1828132
Recalling Firm/
Manufacturer		 Boston Scientific Corp
780 Brookside Dr
Spencer IN 47460-1080
For Additional Information Contact
800-862-1284
Manufacturer Reason
for Recall		Labeling mix-up as to product size; 8FR may be labeled 10FR and vice versa.
FDA Determined
Cause 2		Other
ActionRecall letters dated June 16, 2004 were sent to consignees requesting product return.
Quantity in Commerce550
DistributionNationwide and Netherlands.
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.
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