FDA-Device2024-09-25Class II
vanSonnenberg Sump Locking Pigtail Regular Kit Sump Catheter System Kit, Material Number REF M001273090; for use as a percutaneously placed drain for intra-abdominal fluid collections.
Boston Scientific Corporation
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
4 units
Manufactured in
1 Scimed Pl, Maple Grove, MN, United States
Products
vanSonnenberg Sump Locking Pigtail Regular Kit Sump Catheter System Kit, Material Number REF M001273090; for use as a percutaneously placed drain for intra-abdominal fluid collections.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3150-2024Don't want to check this manually?
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