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

Isulin Pump. Model IR1250

FDA Recall Z-0309-06 · Posted 2005-12-23

Recalling FirmAnimas Corporation
Recall StatusTerminated
Product CodeLZG
Date Initiated2005-10-31
Date Terminated2005-12-23
Product Quantity2 units

Reason for Recall

Pumps were refurbished more than one time for the same failure mode in violation of the company's procedure.

Firm Action

The recalling firm telephoned the users on 10/31/05 to inform them of the problem and that the pump would be replaced if the user choose to return it.

Root Cause

Other

Distribution Pattern

The pumps were shipped to patients CA, CO, FL, IL, KS, MA, MI, NJ, NY, NC, NV, PA,TN, TX, WI, and WV.

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.

↑