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U.S. Department of Health and Human Services

Class 3 Device Recall Mach 1 peripheral Guide Catheter 8F, RDC Renal double Curve, .091 in/ 55cm

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  Class 3 Device Recall Mach 1 peripheral Guide Catheter 8F, RDC Renal double Curve, .091 in/ 55cm see related information
Date Initiated by Firm February 07, 2008
Date Posted May 07, 2008
Recall Status1 Terminated 3 on November 03, 2008
Recall Number Z-1305-2008
Recall Event ID 46785
510(K)Number K010874  K020028  
Product Classification Percutaneous catheter - Product Code DQY
Product Boston Scientific Mach 1 peripheral Guide Catheter 8F, RDC Renal double Curve, .091 in (internal dia), Shaft lenght 55cm, Catalog Number: 19-866, UPN M001198660, Sterile EO, Availmed S.A. de C.V. (Mexico), Boston Scientific Corp., Maple Grove, MN 55311
Code Information Lot Number: 20039169
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
One Boston Scientific Place
Natick MA 01760
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 4
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
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.
510(K) Database 510(K)s with Product Code = DQY and Original Applicant = BOSTON SCIENTIFIC
510(K)s with Product Code = DQY and Original Applicant = BOSTON SCIENTIFIC CORP.
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