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

Recall Z-1602-2013 — Brand Name: Regional Analgesia Infusor System with Patient Control. Indicated for the intravenous administration of medications.

U.S. FDA — Device Enforcement · United States · 2013-06-07 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1602-2013
Date of alert
2013-06-07
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Baxter Healthcare Corp.
Product category
device
Product type
Devices
Reported risk: Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvements which have substantially improved product quality. Complaint rates for ruptures have since decreased. Baxter wants to ensure that no affected product remains in the field.
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.

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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.