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Completed

Enteral Infusion Pump

FDA Recall Z-1347-2021 · Posted None

Recalling FirmCardinal Health 200, LLC
Recall StatusCompleted
Product CodeLZH
Date Initiated2021-01-19
Product Quantity146,944,334 units

Reason for Recall

The potential for air appearing in the enteral feed pumping set tubing during set-up.

Firm Action

On 03/01/2021, Cardinal Health issued an Urgent Medical Device Correction notice to customers via letter to the potential of air entering the feed set tubing of enteral fusion pumps with the specified product codes

Root Cause

Process control

Distribution Pattern

Domestic: All 50 states and DC, Foreign: Argentina, Australia, Brazil, Canada, Chile, Colombia, Japan, Mexico, Netherlands, Panama, Peru, Puerto Rico, Singapore, Switzerland, Turkey

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K040196KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETSTyco Healthcare/Kendall · 2004-05-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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