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

Recall Z-1312-2022 — Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.

U.S. FDA — Device Enforcement · United States · 2022-06-08 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1312-2022
Date of alert
2022-06-08
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Covidien Llc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
8888123400
Reported risk: There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.
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.