Fleixiflo Quantum Enteral Pump.
FDA Recall Z-0145-06 · Posted 2005-11-16
Recalling FirmAbbott Laboratories
Recall StatusTerminated
Product CodeFRN
Date Initiated2005-10-07
Date Terminated2007-08-13
Product Quantity24 devices
Reason for Recall
Pumps have the potential to malfunction and result in a significant over-under delivery of enteral formula.
Firm Action
The recalling firm notified consignees by phone on 10/7/05 and followed up by letter dated 10/7/05.
Root Cause
Other
Distribution Pattern
The device was distributed to 11 hospitals, 5 medical supply customers, and 3 nursing homes located in AL, CA, IN, LA, MI, NC, NH, NY, OH, OK, PA, SC, TN, VA, and WI.
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.