Device Recall Vaxcel PICC with PASV Valve Technology

933284

General Hospital and Personal Use Devices

2

Yes

75 hospitals and medical centers throughout the U.S. One foreign consignee, a hospital in New Brunswick, Canada.

VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen, sold in a kit, Catalog #45-451, UPN #M001454510, Firm on label: Boston Scientific, One Boston Scientific Place, Natick, MA . Manufactured at 10 Glens Falls Technical Park, Glens Falls, NY . DEVICE DESCRIPTION: A radiopaque, polyurethane catheter with a hub/suture wing, polyurethane extension leg(s) and luer locking adapter(s). A peel away sheath introducer allows for percutaneous insertion of the catheter. The hub/suture wing promotes fixation of the catheter hub to the patient''s skin. Each KIT contains catheter, cap; tape measure, 60 cm length; stylet; stylet guide/flush assembly; attachable suture wing; StatLock Catheter Securement Device, Instructions for Use; Peelaway Sheath Introducer; 10 mL Syringe; CSR Wrap.

933285; 982726

General Hospital and Personal Use Devices

2

Yes

75 hospitals and medical centers throughout the U.S. One foreign consignee, a hospital in New Brunswick, Canada.

VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen, sold in a kit, Catalog #45-452; UPN #M001454520. Firm on label: Boston Scientific, One Boston Scientific Place, Natick, MA . Manufactured at 10 Glens Falls Technical Park, Glens Falls, NY . DEVICE DESCRIPTION: A radiopaque, polyurethane catheter with a hub/suture wing, polyurethane extension leg(s) and luer locking adapter(s). A peel away sheath introducer allows for percutaneous insertion of the catheter. The hub/suture wing promotes fixation of the catheter hub to the patient''s skin. Each KIT contains: Catheter; caps; tape measure, 60 cm length;stylet; stylet guide/flush assembly; attachable suture wing; statlock catheter securement device; instructions for use; 21 gauge, 1.5 inch introducer needle with echogenic tip; 30 cm floppy tip guidewire; 5cm peelable introducer sheath with locking dilator; 10 ml syringe; scalpel, CSR wrap.

913405; 924522; 930838; 939045; 950541; 977138; 982727; 3010303254; 3010403103; 3010403104; 3011002260; 3011002261; 3011102036; 3011102037;

General Hospital and Personal Use Devices

2

Yes

75 hospitals and medical centers throughout the U.S. One foreign consignee, a hospital in New Brunswick, Canada.

VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen, sold in kits, Catalog #45-454, UPN #M001454540; Firm on label: Boston Scientific, One Boston Scientific Place, Natick, MA . Manufactured at 10 Glens Falls Technical Park, Glens Falls, NY . DEVICE DESCRIPTION: A radiopaque, polyurethane catheter with a hub/suture wing, polyurethane extension leg(s) and luer locking adapter(s). A peel away sheath introducer allows for percutaneous insertion of the catheter. The hub/suture wing promotes fixation of the catheter hub to the patient''s skin. Each KIT contains: catheter; cap; tape measure, 60 cm length; stylet; stylet guide/flush assembly; attachable suture wing; statlock catheter securement device; instructions for use; 21 gauge, 2.75 inch introducer needle with echogenic tip; 60 cm guidewire with floppy tip platinum tip; 10cm peelable introducer sheath with locking dilator; 10 mL syringe, scalpel; exact length measurement chart.

898658; 898990; 901923; 921920; 931621; 933875; 938673; 939255; 942560; 960665; 961989; 970713; 975113; 982649;

General Hospital and Personal Use Devices

2

Yes

75 hospitals and medical centers throughout the U.S. One foreign consignee, a hospital in New Brunswick, Canada.

VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen: CUSTOM KIT - GENESIS MEDICAL CENTER EAST, Catalog #60M120521, UPN # M00160M1205210; Firm on label: Boston Scientific Corp, NAMIC Technology Center, 10 Glens Falls Technical Park, Glens Falls, NY . DEVICE DESCRIPTION: A radiopaque, polyurethane catheter with a hub/suture wing, polyurethane extension leg(s) and luer locking adapter(s). A peel away sheath introducer allows for percutaneous insertion of the catheter. The hub/suture wing promotes fixation of the catheter hub to the patient''s skin.

876451; 880973; 895705; 895840; 902035; 904140; 912436; 914101; 917478; 920964; 924386; 930246; 933161; 936220; 937349; 941261; 944296; 950194; 951521; 952701; 953969; 956599; 959868; 961578; 963203; 966369; 970121; 977692; 980758; 983865; 985575;

General Hospital and Personal Use Devices

2

Yes

75 hospitals and medical centers throughout the U.S. One foreign consignee, a hospital in New Brunswick, Canada.

PASV PICC CUSTOM KIT, 3F, single lumen - CHILDREN''S HEALTHCARE OF ATLANTA, Catalog # 60M195071, UPN # M00160M1950710. Firm on label: Boston Scientific Corp, NAMIC Technology Center, 10 Glens Falls Technical Park, Glens Falls, NY . DEVICE DESCRIPTION: Each kit contains a radiopaque, polyurethane catheter with a hub/suture wing, polyurethane extension leg(s) and luer locking adapter(s). A peel away sheath introducer allows for percutaneous insertion of the catheter. The hub/suture wing promotes fixation of the catheter hub to the patient''s skin.