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Class 2 Device Recall Boston Scientific Super Sheath and Super Sheath R/O Introducer Sheaths |
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Date Initiated by Firm |
November 03, 2011 |
Date Posted |
November 21, 2011 |
Recall Status1 |
Terminated 3 on January 15, 2013 |
Recall Number |
Z-0264-2012 |
Recall Event ID |
60365 |
510(K)Number |
K052557
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Product Classification |
Dilator, vessel, of percutaneous catherization - Product Code DRE
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Product |
Boston Scientific Super Sheath and Super Sheath R/O Introducer Sheaths, Sterile EO, Manufactured by Togo Medikit Co., Ltd. 17148-6 Aza Kamekawa, Oaza Hichiya, Hyuga City, Miyazaki Prefecture 883-0062, Japan, Distributed by Boston scientific Corporation One Boston Scientific Place, Natick, MA 01760-1537 USA.
Super Sheath 8F x 11 cm ,038 with Guide Wire BX/10 UPN H7491603508B1, Catalog # 16035-08B. Batch/Lot 11B15B6, 11B23B7, 11B28B9, 11C09BA, 11C16B9, 11C30B9.
Super Sheath 8F x 11 cm ,038 without Guide Wire BX/10 , U PN M00115724B1, Catalog # 15-724B1. Batch/Lot 11C07B8.
Super Sheath R/O 8 F x 11 cm without Guide Wire BX/10, M00159664B1, Catalog # 15-964B, Batch/Lot 11B01B4, 11B25B6.
The device is indicated for use in the introduction of diagnostic and interventional devices inserted into the human vasculature.
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Code Information |
11B15B6 11B23B7 11B28B9 11C09BA 11C16B9 11C30B9 11C07B8 11B01B4 11B25B6 |
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
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Manufacturer Reason for Recall |
Boston Scientific is initiating a medical device recall removal regarding nine lots/batches of Super Sheath and Super Sheath R/O Introducer Sheaths. Boston Scientific was informed through product complaints that the 0.035" ID dilator may be labeled incorrectly as a 0.038" ID dilator.
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FDA Determined Cause 2 |
Packaging process control |
Action |
Boston Scientific sent an URGENT MEDICAL DEVICE RECALL REMOVAL -IMMEDIATE ACTION REQUIRED letter dated November 21, 2011. The letter described the product and the problem. Customers were instructed to segregate the affected product immediately and return it to Boston Scientific. Distributors were advised that the recall removal depth is to the hospital level and the recall removal notification should be forwarded to their customers.
For questions regarding this recall call 763-494-1133. |
Quantity in Commerce |
2660 |
Distribution |
Worldwide Distribution - USA including AZ, AR, CA, CO, FL, GA, IL, KY, LA, MD, MA, MN, MO, NE, NJ, NM, NY, OH, OK PA, RI, TN, TX, UT, VA, WY, WI, and WV and the countries of BELGIUM, BRAZIL, CZECH REPUBLIC, FRANCE, GERMANY, GREAT BRITAIN, IRAQ, ITALY, NETHERLANDS, RUSSIAN FEDERATION, SOUTH KOREA, SPAIN, SWEDEN, and UKRAINE. |
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 = DRE and Original Applicant = TOGO MEDIKIT CO., LTD.
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