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Terminated

Animas IR 1250 Insulin Pump.

FDA Recall Z-0929-05 · Posted 2005-06-25

Recalling FirmAnimas Corporation
Recall StatusTerminated
Product CodeLZG
Date Initiated2005-04-11
Date Terminated2006-01-24
Product Quantity2081 units

Reason for Recall

pump failed to respond to keypad button pressess after using the food database feature

Firm Action

The recalling firm issued a recall notice dated 4/11/05 to all patients and healthcare providers via first class mail. The letter instructs the patient to reset the pump, thus correcting any problems caused by the software bug, and to discontinue use of the food database. All distributors were contacted by phone on 4/12/05 and instructed to return all pumps in their inventory. On 4/25/05, the recalling began emailing and telephoning patients to arrange for replacement and return of the devices.

Root Cause

Other

Distribution Pattern

The products were shipped to distributors in FL, TX, UT, and VA. The products were also shipped to patients nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K042873ANIMAS MODEL IR1250 INSULIN INFUSION PUMPAnimas Corp. · 2004-12-10

Official Source

View FDA Recall →

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

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