—#33053

Product

Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panomat P, Panomat T, Panomat V and Dahedi Infusion pumps and Pen 10 insulin pens in box of 25 cartridges, 25 needles; manufactured by Disetronic Medical Systems AG, CH-3401, Burgdorf, Switzerland; catalog number 300.0419.

FDA product code: LZG — Pump, Infusion, Insulin
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K973044
Affected lot / code info: All lots.

Why it was recalled

Lack of assurance of sterility.

Root cause (FDA determination)

Other

Action the firm took

The firm issued recall letters dated 5/17/04 to all users. A dear doctor letter issued to prescribers instructing them to discontinue prescription of the glass cartridges.

Recalling firm

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

Distribution

Distribution pattern: Worldwide.

Timeline

Recall initiated: 2004-05-17
Posted by FDA: 2004-07-20
Terminated: 2006-05-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #33053. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.