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Terminated

ambIT Ambulatory Infusion Therapy Intermittent Pump

FDA Recall Z-1188-06 · Posted 2006-07-01

Recalling FirmSorenson Medical, Inc.
Recall StatusTerminated
Product CodeFRN
Date Initiated2006-05-03
Date Terminated2006-08-09
Product Quantity72 pumps

Reason for Recall

Intermittent Infusion pump may continually dispense medication under certain conditions.

Firm Action

All direct accounts were contacted by email and phone on 05/03/2006. Distributors were instructed to identify end users for Recalling Firm notification

Root Cause

Other

Distribution Pattern

Worldwide distribution (including-states of IL, KS, NJ, PA, WA. , countries of Germany, Malaysia, New Zealand, Slovenia.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K033425AMBIT INTERMITTENT AMBULATORY INFUSION PUMPSorenson Medical, Inc. · 2003-11-06

Official Source

View FDA Recall →

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

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