Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-3150-2024 — 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.

U.S. FDA — Device Enforcement · United States · 2024-07-18 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-3150-2024
Date of alert: 2024-07-18
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Boston Scientific Corporation
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 0871472913774

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-3150-2024 — 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.

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