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Terminated

IR 1200 Insulin Pump. IPX8 Rx only. Label P/N 400-125-00 Revision C.

FDA Recall Z-0211-05 · Posted 2004-11-19

Recalling FirmAnimas Corporation
Recall StatusTerminated
Product CodeLZG
Date Initiated2004-09-28
Date Terminated2005-03-10
Product Quantity7395 units

Reason for Recall

Suspend mode not functioning properly

Firm Action

The recalling firm issued a notice entitled 'Important Safety Information Regarding the Animas IR 1200 Pump' dated 9/28/04 to the health care professionals and distributors. The letter informed the reader of the problem and to use an alternate feature. Health care professionals should notify patients of the problem.

Root Cause

Other

Distribution Pattern

The products are shipped to diabetic supply companies in FK, NE, NV, NJ, NY, OH, OK, TX, VA, and WA then further shipped to patients nationwide. The products were shipped to government accounts in IL, MD, and SC. The product was also shipped to a supply company in Israel.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K032257MODEL IR 1200 INSULIN PUMPAnimas Corp. · 2003-10-16

Official Source

View FDA Recall →

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

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