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

Recall Z-1271-2018 — 8F Plastic Dignity¿ Low Profile CT Port W/Pre-Attached ChronoFlex¿ Polyurethane Catheter

U.S. FDA — Device Enforcement · United States · 2017-11-22 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1271-2018
Date of alert
2017-11-22
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Medical Components, Inc dba MedComp
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
884908110449
Reported risk: The kit was packaged with the incorrect guidewire. The label indicates the kit contains a marked guidewire. The kits were packaged with an unmarked guidewire.
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.