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U.S. Department of Health and Human Services

Class 2 Device Recall Flexima and Percuflex Drainage Catheter Family (Pigtail Style)

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 Class 2 Recall
Flexima and Percuflex Drainage Catheter Family (Pigtail Style)
see related information
Date Posted May 21, 2009
Recall Status1 Open
Recall Number Z-1333-2009
Recall Event ID 51334
Premarket Notification
510(K) Numbers
K023870  K811378  K820867  K900205  K944290 
Product Classification Tube, Drainage, Suprapubic - Product Code FFA
Product Boston Scientific, Flexima® and Percuflex® Drainage Catheter Family (Pigtail Style) UPN DESCRIPTION M001271540 FLEXIMA BILIARY FIRM 8F/35CM M001271550 FLEXIMA BILIARY FIRM 10F/35CM M001271560 FLEXIMA BILIARY REG 8F/35CM M001271570 FLEXIMA BILIARY REG 10F/35CM M001271580 FLEXIMA BILIARY REG 12F/35CM M001271590 FLEXIMA BILIARY REG 14F/35CM M001271600 FLEXIMA BILIARY SOFT 10F/35CM M001271610 FLEXIMA BILIARY SOFT 12F/35CM M001271620 FLEXIMA BILIARY SOFT 14F/35CM M001281560 FLEXIMA BILIARY 8/35 TT M001281570 FLEXIMA BILIARY 10/35 TT M001281580 FLEXIMA BILIARY 12/35 TT M001281590 FLEXIMA BILIARY 14/35 TT M001271630 FLEXIMA BIL 8F/35CM FIRM KIT M001271640 FLEXIMA BIL 10F/35CM FIRM KIT M001271650 FLEXIMA BIL 8F/35CM REG KIT M001271660 FLEXIMA BIL 10F/35CM REG KIT Single Use Only, Sterilized with Ethylene Oxide Gas, Boston Scintific Corporation, One Boscton Scintific Place, Natick, MA 01760-1537, Made in USA 780 Brookside Drive, Spencer, IN 47460 1080. Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract.
Code Information All codes
Recalling Firm/
Manufacturer
Boston Scientific Corporation
1 Scimed Pl
Maple Grove, Minnesota 55311-1565
Manufacturer Reason
for Recall
Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima¿ and Percuflex¿ Drainage Catheter Family (Pigtail Style). During the attempted removal of the device, sutures were separated from the catheter and remained in the patient.
FDA Determined
Cause 2
MISBRANDING: Labeling False and Misleading
Action Consignees were sent a Boston Scientific " Urgent Medical Device Field Correction Notification" letter dated March 18, 2009. The letter was addressed to "The Hospital Field Action Contact". The letter described the problem, product affected and the revised catheter removal instructions. They also requested the return of the Acknowledgement Form.
Quantity in Commerce 586,276 US; 276,013 OUS total for all products
Distribution Worldwide Distribution -- USA including DC, Puerto Rico and Guam and countries of United Arab Emirates Austria, Bosnia and Herzegovina, Bahrain, Switzerland, Germany, Egypt, Spain, Finland, France, Great Britain, Ireland, Italy, Kuwait, Netherland, Pakistan, Portugal, Saudi Arabia, Sweden, Slovak Republic, Tunisia, Turkey, South Africa, Netherlands, Costa Rica, Japan, Argentina, Australia, Brazil, Canada, Chile, China, Columbia, Ecuador, El Salvador, Guatemala, Honduras, Hong Kong, Macau, Malaysia, Mexico New Zealand, Panama, Peru, Philippines, Puerto Rico, Singapore, South Korea, Sri Lanka, Taiwan, Thailand, Uruguay, and Venezuela.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FFA and Original Applicant = BOSTON SCIENTIFIC CORP.
510(K)s with Product Code = FFA and Original Applicant = BOSTON SCIENTIFIC/MEDI-TECH
510(K)s with Product Code = FFA and Original Applicant = MEDI-TECH, INC.
510(K)s with Product Code = FFA and Original Applicant = VAN-TEC, INC.
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