Boston Scientific Corporation recalls Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001271960, b) REF M001271970; all-purpose drai…

Recall date

July 18, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3147-2024

FDA classification

Class II

Brand / firm

Boston Scientific Corporation

Sold / distributed

US, Colombia, Philippines, Russia

Why it was recalled

There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001271960, b) REF M001271970; all-purpose drainage catheter with locking pigtail