FDA-Device2024-09-25Class II
Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001271960, b) REF M001271970; all-purpose drainage catheter with locking pigtail
Hazard
There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
Sold states
US, Colombia, Philippines, Russia
Affected count
89 units
Manufactured in
1 Scimed Pl, Maple Grove, MN, United States
Products
Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001271960, b) REF M001271970; all-purpose drainage catheter with locking pigtail
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3147-2024More Boston Scientific Corporation recalls
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