Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Disetronic D-TRONplus Insulin Pump Battery Pack; Ref/Catalog no. 04697014001.

FDA Recall Z-1413-06 · Posted 2006-09-12

Recalling FirmDisetronic Medical Systems, Inc.
Recall StatusTerminated
Product CodeLZG
Date Initiated2006-07-13
Date Terminated2007-11-05
Product Quantity6,604 packs to U.S. and Canada.

Reason for Recall

The battery may turn the pump off without warning due to a design change in the battery.

Firm Action

Press release was issued on 7/13/06. Consignees, distributors and health care providers were issued a recall notice dated 7/13/06 instructing replacement of the power pack every two weeks until further notice.

Root Cause

Other

Distribution Pattern

Nationwide and Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K043000MODIFICATION TO D-TRONPLUSDisetronic Medical Systems AG · 2004-12-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑