Cl II Animas Vibe Insulin Infusion Pump

Company: Annimas Corp.
Date of Enforcement Report 2/11/2015
Class lI:

PRODUCT

Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a continuous glucose monitoring feature. Recall Number Z-1034-2015

REASON
ICalibration factors in the pump overwritten during a programming step. The force sensor could send a lower signal value to the pump processor, with loss of prime warnings, occlusion alarms and the pump unable to detect a cartridge during the prime sequence. Field action initiated 8/29/2011.

RECALLING FIRM/MANUFACTURER
Animas Corporation, West Chester, PA 9/6/2011. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1235

DISTRIBUTION
No US distribution, Distributors are located in France, Germany, Sweden and United Kingdom.

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