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RECALLS AND FIELD CORRECTIONS 7

RECALLS AND FIELD CORRECTIONS 7 - Enforcement Report for...

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Enforcement Report for September 22, 2010 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II ___________________________________ PRODUCT 1) FLEXIMA Biliary Stent System, 7Fr-5cm, M00539200, Sterile EO. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone. Recall # Z-1975- 2010; 2) FLEXIMA Biliary Stent System, 7Fr-7cm, M00539210, Sterile EO. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone. Recall # Z-1976- 2010; 3) FLEXIMA Biliary Stent System, 7Fr-10cm, M00539220, Sterile EO. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone. Recall # Z- 1977-2010; 4) FLEXIMA Biliary Stent System, 7Fr-12cm, M00539230, Sterile EO. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone. Recall # Z- 1978-2010; 5) FLEXIMA Biliary Stent System, 7Fr-15cm, M00539240, Sterile EO. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone. Recall # Z- 1979-2010; 6) FLEXIMA Biliary Stent System, 8.5Fr-5cm, M00539250, Sterile EO. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone. Recall # Z- 1980-2010; 7) FLEXIMA Biliary Stent System, 8.5Fr-7cm, M00539260, Sterile EO. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone. Recall # Z- 1981-2010; 8) FLEXIMA Biliary Stent System, 8.5Fr-10cm, M00539270, Sterile EO. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone. Recall # Z- 1982-2010;
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Enforcement Report for September 22, 2010 9) FLEXIMA Biliary Stent System, 8.5Fr-12cm, M00539280, Sterile EO. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone. Recall # Z- 1983-2010; 10) FLEXIMA Biliary Stent System, 8.5Fr-15cm, M00539290, Sterile EO. The Flexima Biliary Stent
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