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

Recall Z-1987-2016 — BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965458980, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system fo

U.S. FDA — Device Enforcement · United States · 2016-03-14 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1987-2016
Date of alert: 2016-03-14
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Navilyst Medical, Inc., an AngioDyamics Company
Product category: device
Product type: Devices

Reported risk: PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter.

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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