Boston Scientific Corporation 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 prom Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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 prom
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
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
Products Sold
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;
Boston Scientific Corporation is recalling PASV PICC CUSTOM KIT, 3F, single lumen - CHILDREN''S HEALTHCARE OF ATLANTA, Catalog # 60M195071, UPN due to Catheter separation immediately distal to the nose of the suture wing.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Catheter separation immediately distal to the nose of the suture wing.
Recommended Action
Per FDA guidance
Letters dated 11/22/2004 issued via Certified Mail. Customers instructed to return units in inventory. Patients with implanted units are to be evaluated.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN
Page updated: Jan 10, 2026