Recalls / —

—#186052

Product

Enteral Infusion Pump

FDA product code

LZH — Pump, Infusion, Enteral

Device class

Class 2

Medical specialty

General Hospital

510(k) numbers

K040196

Affected lot / code info

Catalog Number: 612054, 613650, 614650, 672055, 673656, 673662, 674655, 674668, 674669, 716154, 762055, 763656, 763662, 765100, 765559, 772055, 773656, 773662, 775100, 775659, 776150

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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

Recalling firm

Firm

Cardinal Health 200, LLC

Address

3651 Birchwood Dr, Waukegan, Illinois 60085-8337

Distribution

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

Timeline

Recall initiated

2021-01-19

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #186052. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.