| Class 2 Device Recall Boston Scientific, Fort | |
Date Initiated by Firm | May 12, 2009 |
Date Posted | June 24, 2009 |
Recall Status1 |
Terminated 3 on December 11, 2011 |
Recall Number | Z-1487-2009 |
Recall Event ID |
52098 |
510(K)Number | K011968 |
Product Classification |
intravascular guide wire - Product Code DQX
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Product | Boston Scientific, Fort Guide Wire, Floppy, 300cm x 2 cm REF 34949-04, for use in intravascular interventional procedures. |
Code Information |
01403876 |
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 |
Manufacturer Reason for Recall | Product packaged incorrectly. One batch/lot of wires, that should contain radiopaque marker bands, is missing the marker bands; and a second batch/lot of wires, which should not contain radiopaque marker bands, has the marker bands. Since the marker bands issue would not be visually apparent to the physician there is a potential for prolongation or delay of the procedure in order to exchange the |
FDA Determined Cause 2 | Process control |
Action | Consignees were sent a "Boston Scientific Urgent Medical Device Recall" letter dated may 19, 2009. The letter was addressed to "Dear Risk Manger/ Field Action Contact". The letter described the problem, customer steps for recall and listing of product batches / lots. The letter requested consignees to return the Reply Verification Tracking Form. |
Quantity in Commerce | Total of 4 boxes (5 units /box). |
Distribution | USA distribution: AR, MO, CA, FL, and NV. |
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
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