Recalls / —

—#28555

Product

Disetronic Dahedi insulin infusion pump; catalog # 8500019.

FDA product code

LZG — Pump, Infusion, Insulin

Device class

Class 2

Medical specialty

General Hospital

510(k) numbers

K991376

Affected lot / code info

All units

Why it was recalled

Lack of assurance of reliability.

Root cause (FDA determination)

Other

Action the firm took

A recall letter dated 8/5/03 was issued to each user instructing them that they will receive a new pump and, upon receipt of the new pump, they will be required to return their Dahedi pump to the firm's representative.

Recalling firm

Firm

Roche Diagnostics Corp.

Address

9115 Hague Road, Indianapolis, Indiana 46250-0457

Distribution

Distribution pattern

United States.

Timeline

Recall initiated

2003-07-28

Posted by FDA

2003-09-23

Terminated

2007-01-12

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #28555. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.