BEUDAMED
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    TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 1 configuration) Universal Product Number (UPN): M00561410. Distributed by: Boston Scientific. Manufactured by: Horizons International Corp. Intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as polyps and food boluses.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·January 22, 2014

    TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 5 configuration) Universal Product Number (UPN): M00561411. Distributed by: Boston Scientific. Manufactured by: Horizons International Corp. Intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as polyps and food boluses.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·January 22, 2014

    TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 10 configuration) Universal Product Number (UPN):M00561412. Distributed by: Boston Scientific, Natick, MA. Manufactured by: Horizons International Corp., Costa Rica Intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as polyps and food boluses.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·January 22, 2014

    TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 10 configuration) Intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as polyps and food boluses. Universal Product Number (UPN):M00561422 Distributed by: Boston Scientific, Natick, MA. Manufactured by: Horizons International Corp., Costa Rica.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·January 22, 2014

    TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 1 configuration) Universal Product Number (UPN):M00561420. Distributed by: Boston Scientific, Natick, MA. Manufactured by: Horizons International Corp., Costa Rica Intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as polyps and food boluses.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·January 22, 2014

    TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 5 configuration) Universal Product Number (UPN):M00561421. Distributed by: Boston Scientific, Natick, MA. Manufactured by: Horizons International Corp., Costa Rica. Intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as polyps and food boluses.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·January 22, 2014

    One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corp·December 16, 2015

    Implantable Chest Ports labeled: Titanium Single Lumen Port with PASV valve and 6.6F Silicone Catheter. Boston Scientific Cat. # PRTA66P M001PRTA66P0. Firm on label: Boston Scientific Natick, MA and Boston Scientific Corp., Glens Falls, NY.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code LJS·October 28, 2005

    Vaxcel Low Profile Port with PASV valve and 8F Silicone Catheter. CATALOG NO. 45-236, Ref. # M001452360. FIRM ON LABEL: Boston Scientific MEDI-TECH. Manufactured for: Boston Scientific Corp., One Boston Scientific Place, Natick, MA 01760-1537. Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code LLD·February 25, 2005

    Vaxcel Low Profile Port with PASV Valve and 6F Polyurethane Catheter. CATALOG NO. 45-233. Ref. # M001452330. FIRM ON LABEL: Boston Scientific MEDI-TECH. Manufactured for: Boston Scientific Corp., One Boston Scientific Place, Natick, MA 01760-1537. Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code LLD·February 25, 2005

    Vaxcel Low Profile Port with PASV valve and 8F Polyurethane Catheter. CATALOG NO. 45-238, Ref. # M001452380. FIRM ON LABEL: Boston Scientific MEDI-TECH. Manufactured for: Boston Scientific Corp., One Boston Scientific Place, Natick, MA 01760-1537. Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code LLD·February 25, 2005

    Vaxcel Implantable Vascular Access System - Titanium Mini-Port with PASV Valve and 8F Silicone Catheter, REF/Catalog No. 45-220, UPN/Material No. M001452200,

    FDA Recall
    Terminated ·Boston Scientific Corp·Product code LJT·September 27, 2006

    Vaxcel Implantable Vascular Access System - Titanium Mini-Port with PASV Valve and 8F Polyurethane Catheter, REF/Catalog No. 45-215, UPN/Material No. M001452150,

    FDA Recall
    Terminated ·Boston Scientific Corp·Product code LJT·September 27, 2006

    Boston Scientific Mach 1 peripheral Guide Catheter 6F, HS Hockey Stick, .070 in (internal dia), Shaft lenght 55cm, Catalog Number: 19-600, UPN M001196000, Sterile EO, Availmed S.A. de C.V. (Mexico), Boston Scientific Corp., Maple Grove, MN 55311

    FDA Recall
    Terminated ·Boston Scientific Corporation One Boston·Product code DQY·February 7, 2008

    Boston Scientific Mach 1 Guide Catheter 6F, IM Internal Mammary 90cm, .070 in (internal dia), shaft lenght, 90 cm, Catalon Number: 34356-446, UPN H749343564460, Sterile EO, Availmed S.A. de C.V. (Mexico), Boston Scientific Corp., Maple Grove, MN 55311

    FDA Recall
    Terminated ·Boston Scientific Corporation One Boston·Product code DQY·February 7, 2008

    Boston Scientific Mach 1 peripheral Guide Catheter 6F, RDC Renal double Curve, .070 in (internal dia), Shaft lenght 55cm, Catalog Number: 19-666, UPN M001196660, Sterile EO, Availmed S.A. de C.V. (Mexico), Boston Scientific Corp., Maple Grove, MN 55311

    FDA Recall
    Terminated ·Boston Scientific Corporation One Boston·Product code DQY·February 7, 2008

    Boston Scientific Mach 1 peripheral Guide Catheter 7F, MP Multipurpose, .081 in (internal dia), Shaft lenght 55cm, Catalog Number: 19-723, UPN M001197230, Sterile EO, Availmed S.A. de C.V. (Mexico), Boston Scientific Corp., Maple Grove, MN 55311

    FDA Recall
    Terminated ·Boston Scientific Corporation One Boston·Product code DQY·February 7, 2008

    Boston Scientific Mach 1 peripheral Guide Catheter 6F, MP Multipurpose 90cm, .070 in (internal dia), Shaft lenght 90cm, Catalog Number: 19-626, UPN M001196260, Sterile EO, Availmed S.A. de C.V. (Mexico), Boston Scientific Corp., Maple Grove, MN 55311

    FDA Recall
    Terminated ·Boston Scientific Corporation One Boston·Product code DQY·February 7, 2008

    Boston Scientific Mach 1 peripheral Guide Catheter 8F, RDC Renal double Curve, .091 in (internal dia), Shaft lenght 55cm, Catalog Number: 19-866, UPN M001198660, Sterile EO, Availmed S.A. de C.V. (Mexico), Boston Scientific Corp., Maple Grove, MN 55311

    FDA Recall
    Terminated ·Boston Scientific Corporation One Boston·Product code DQY·February 7, 2008

    One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube.

    FDA Recall
    Terminated ·Boston Scientific Corp·Product code KGC·September 11, 2015