| Class 3 Device Recall Mach 1 peripheral Guide Catheter 6F, HS Hockey Stick, .070 in/ 55cm | |
Date Initiated by Firm | February 07, 2008 |
Date Posted | May 07, 2008 |
Recall Status1 |
Terminated 3 on November 03, 2008 |
Recall Number | Z-1301-2008 |
Recall Event ID |
46785 |
510(K)Number | K010874 K020028 |
Product Classification |
Percutaneous catheter - Product Code DQY
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Product | Boston Scientific Mach 1 peripheral Guide Catheter 6F, HS Hockey Stick, .070 in (internal dia), Shaft lenght 55cm, Catalog Number: 19-600, UPN M001196000, Sterile EO, Availmed S.A. de C.V. (Mexico), Boston Scientific Corp., Maple Grove, MN 55311 |
Code Information |
Lot Number: 20025890 |
Recalling Firm/ Manufacturer |
Boston Scientific Corporation One Boston Scientific Place Natick MA 01760
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For Additional Information Contact | 800-272-3737 |
Manufacturer Reason for Recall | Mislabeled: Seven lots/ batches of Boston Scientific Mach 1 Guide Catheter may be mislabeled with the incorrect device length. |
FDA Determined Cause 2 | Labeling mix-ups |
Action | Consignees were sent a Boston Scientific Urgent Voluntary Medical Device Recall letter on 2/7/08. The letter included the customer steps for recall, a complete listing of all product batches being recalled, the Reply Verification Tracking Form(s) and a return shipping label. |
Quantity in Commerce | 9 |
Distribution | Worldwide Distribution including USA states of PA, AZ, NY, KY, CA, WV, OH, WA, MI, TN, IN, IL, NJ, KY, FL, AR, FL, NC, CO, TX, WV, WI, OR, AL, MN and ND and countries of BE, FR, GB, DE, IE, IT, JP, AU, SOUTH KOREA, NZ, TR, TW and ZA. |
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 = DQY 510(K)s with Product Code = DQY
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