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Terminated

Disetronic D-Tronplus Insulin Pump adapters; Ref 3000803; catalog reference number 0457243001 sold in packages of ten adapters.

FDA Recall Z-1105-05 · Posted 2005-08-06

Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeLZG
Date Initiated2005-07-15
Date Terminated2006-02-07
Product Quantity107 pediatric patients use the device.

Reason for Recall

The adapter valve may not operate correctly, which may result in overdelivery of insulin in the first dose after the adapter has been changed.

Firm Action

The firm began notifying family members of pediatric patients via phone on 7/15/05 and immediately began shipping a recall letter and 10 packs of replacement adapters to each pediatric user. Attending physicians were for these pediatric patients were notified the week of 7/18/05 via phone and follow-up letters were sent to these physicians. The firm is issuing a press release on 7/28/05. Only these replacement adapters are being sold by Disetronic to users of any age ordering new adapters.

Root Cause

Other

Distribution Pattern

Nationwide.

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.

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