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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientifc

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  Class 2 Device Recall Boston Scientifc 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-1464-05
Recall Event ID 32694
510(K)Number K961219  
Product Classification Catheter, Suprapubic (And Accessories) - Product Code KOB
Product Banana Peel™ Sheaths BP/14/15
Catalog Number: 20-609
Code Information Lot numbers:  6369319 6392604 6412087 6440250 6458182 6502513 6525652 6537822 6552545 6585322 6599018 6620745 6646571 6661841 6697321 6722536 6774278 6803135 6823846 6844314 6854850 6938751 6956397 6973991 7012895 7042711 7069901 7088270 7105143 7196764 7235415 7358084 7382687 7401686 7456767 7469359 7495157 7552030 7571547 7596737 7630036 7639884 7739648  
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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