Recall Z-0764-2013— MOOG Medical Devices Group
Class II · Terminated
Class II FDA medical device recall by MOOG Medical Devices Group, initiated 2012-10-12, terminated 2014-04-10. It names one FDA 510(k) clearance: K031199. Product: 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.. Reason: 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..
- Recalling firm
- MOOG Medical Devices Group
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-10-12
- Terminated
- 2014-04-10
- Firm location
- Salt Lake City, UT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.