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

Recall Z-0595-2019 — Xcela Power Injectable PICC with PASV (XCELA PASV 4F SL 55CM Catheter Kit CE PG), Cat no. 55-711

U.S. FDA — Device Enforcement · United States · 2018-10-16 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0595-2019
Date of alert
2018-10-16
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Angiodynamics Inc. (Navilyst Medical Inc.)
Product category
device
Product type
Devices
Reported risk: Specific lots of Xcela Power Injectable and BioFlo PICCs are labelled with incorrect expiration dates. The labelled expiration date extends the shelf life of the product beyond the date supported by validation testing. Although the product under recall has not yet reached its validated expiry date, removal of the affected product is warranted to prevent use beyond the validated expiry date.
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.