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

Recall Z-0564-2015 — 6F x 60 cm Dual Lumen CT PICC, Ref No. PFM2CT6D Product Usage:The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, and power injection of contrast media. For blood sampling, infusions, or therapies, use a 4F or larger

U.S. FDA — Device Enforcement · United States · 2014-10-20 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0564-2015
Date of alert: 2014-10-20
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Pfm Medical Inc
Product category: device
Product type: Devices

Reported risk: PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.

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

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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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