Z-1222-04

Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panomat P, Panomat T...

Name: Z-1222-04 Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panomat P, Panomat T...
Creator: Roche Diagnostics Corp.
Published: 2004-05-17
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2004-05-17 / Terminated / root cause: sterility

FDA source

Roche Diagnostics Corp. began a recall of 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... on 2004-05-17. The reason FDA records is "Lack of assurance of sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1222-04
Status: Terminated
Initiated: 2004-05-17
Posted: 2004-07-20
Terminated: 2006-05-10
Recalling firm: Roche Diagnostics GmbH
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 10 x 10 box (10 cartidges per blister pack; 10 blister packs per box; Manufactured by Disetronic Medical Systems AG, CH-3401, Burgdorf, Switzerland; catalog number 150.0157.
Product code: LZG Pump, Infusion, Insulin
Reason for recall: Lack of assurance of sterility.
Root cause tag: sterility
FDA root cause: Other
Action: 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.
Distribution: Worldwide.
Product codes and lots: All lots.

Product code LZG

K973044Class IIDisetronic H-Tron Plus V 100 Insulin Infusion PumpDisetronic Medical Systems / cleared 1997-09-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)