—#28288

Product

Disetronic H-TRONplus Insulin Pump; catalog # 8050023 [clear case], 8050064 [blue case], 8050021 [solid-color case] and 8050071 [yellow case].

FDA product code: LZG — Pump, Infusion, Insulin
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K023471
Affected lot / code info: All units.

Why it was recalled

Lack of assurance of reliability, due to quality system regulations violations, plus notice to users not to expose pump to water.

Root cause (FDA determination)

Other

Action the firm took

An urgent product correction and removal letter dated 7/16/03 was issued to each pump user informing of potential problems with the pump and instructing them how to proceed if they wish to discontinue use of the pump, have it replaced, or have questions regarding the pump.

Recalling firm

Firm: Roche Diagnostics Corp.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: United States

Timeline

Recall initiated: 2003-07-21
Posted by FDA: 2003-09-17
Terminated: 2009-03-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #28288. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.