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

Recall Z-2382-2015 — Celsite Implantable Access Port System, model ST301. The Celsite Implantable Access Port Systems (Celsite port systems) are implantable port and catheter systems that allow safe, repeated access to the patient's bloodstream. The port chamber and catheter design can be used for the administration o

U.S. FDA — Device Enforcement · United States · 2015-06-16 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2382-2015
Date of alert: 2015-06-16
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: B. Braun Interventional Systems
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 36896615

Reported risk: The manufacturer, B. Braun medical France, received endotoxin test results that are out of specification for the peelable sheath (A1537).

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.

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