Infinity Enteralite Ambulatory Feeding Pumps, List number: INFKIT2 - Addendum to Operator's Manual Product usage: provide a means for the volumetric delivery of fluids used in Enteral applications.
FDA Recall Z-0764-2013 · Posted 2013-01-31
Recalling FirmMOOG Medical Devices Group
Recall StatusTerminated
Product CodeLZH
Date Initiated2012-10-12
Date Terminated2014-04-10
Product Quantity92,488 units
Reason for Recall
The firm is adding an addendum to the operator's manual for Infinity Enteralite Ambulatory Feeding Pumps pertaining to the Infinite Dose mode and the inability of the Pump to detect air in line.
Firm Action
An Urgent Field Safety Notice was sent to all original consignees by certified mail beginning on Monday, October 15, 2012. Consignees were provided with an Addendum to the Operator's Manual as part of the Notice. Consignees were instructed to assure pump users are aware of the information in the addendum and to store the addendum with the Operator's Manual. Consignees were also requested to complete and return a Medical Device Recall reply form to the firm. For additional information or clarification, consignees are to contact Holly Imes, Manager, Regulatory Affairs at 801-264-1001, ext. 230 or via email at: [email protected].
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution and US Nationwide in the countries of (Germany, Sweeden, Croatia, Lithuania, and Dubai).
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.