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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific

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  Class 2 Device Recall Boston Scientific see related information
Date Initiated by Firm July 22, 2005
Date Posted September 02, 2005
Recall Status1 Terminated 3 on June 20, 2007
Recall Number Z-1477-05
Recall Event ID 32694
510(K)Number K030083  
Product Classification Catheter, Suprapubic (And Accessories) - Product Code KOB
Product Vaxcel¿ Chest Ports - Mini/T/S/8/1.5/2.6/63
Catalog Number : 45-310
Code Information Lot Numbers: 897963 899779 905283 905540 905795 912253 912714 918871 919149 920316 926376 926666  934740 935754 937478 938097 938491 942049 942282 948073  953631 958509 958815 959675 968284 968734 969544 970794  972100 974707 975769 976229 978021 980595 981357 991171  991172 991173 991174 991438 992989 1000900 1000901 1000902 1001276 1002352  
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
1 Boston Scientific Pl
Natick MA 01760-1536
For Additional Information Contact Cindy Finney
508-683-4678
Manufacturer Reason
for Recall		 The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
FDA Determined
Cause 2		 Other
Action Boston Scientific intiated the recall on 7/22/05 to direct accounts and to distributors on 7/ 27 /05. Distributors are requested to conduct sub recalls to the medical facility level. A revised letter dated 8/2/05 was sent to 18 US accounts for one lot (#1020895) omitted in the letter of 7/22/05.
Distribution Nationwide VA Hopsitals Foreign: Canada, Africa, Japan, Israel, Japan, Nertherlands, Venezula
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 = KOB and Original Applicant = BOSTON SCIENTIFIC CORP.
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