Date Initiated by Firm | July 01, 2003 |
Date Posted | August 12, 2003 |
Recall Status1 |
Terminated 3 on December 28, 2006 |
Recall Number | Z-1096-03 |
Recall Event ID |
26708 |
510(K)Number | K021735 |
Product Classification |
unknown device name - Product Code GBR
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Product | Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm / 1.5 cm /90 cm (balloon width/balloon length/catheter length), Reference Catalog Number 37915-4015 |
Code Information |
Lot numbers 5490976, 5530109, and 5564475 |
Recalling Firm/ Manufacturer |
Boston Scientific Scimed One Scimed Place Maple Grove MN 55311-1566
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For Additional Information Contact | Patrick Burt 763-494-1192 |
Manufacturer Reason for Recall | Some of the product pouches have holes in the seals. |
FDA Determined Cause 2 | Other |
Action | Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them. |
Quantity in Commerce | 42 |
Distribution | The recalled products were shipped to hospitals located nationwide in the United States. |
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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 = GBR
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