Recalls / —

—#42363

Product

Fleixiflo Quantum Enteral Pump.

FDA product code

FRN — Pump, Infusion

Device class

Class 2

Medical specialty

General Hospital

510(k) numbers

K944669

Affected lot / code info

Serial numbers 1003276, 1022603, 1025074, 1027378, 1028541, 1049161, 1056343, 1056908, 1057323, 1057967, 1058939, 1059103, 1059366, 1059614, 1059641, 1059857, 1059892, 1059945, 1060026, 1060188, 1061131, 1061355, 1061492.

Why it was recalled

Pumps have the potential to malfunction and result in a significant over-under delivery of enteral formula.

Root cause (FDA determination)

Other

Action the firm took

The recalling firm notified consignees by phone on 10/7/05 and followed up by letter dated 10/7/05.

Recalling firm

Firm

Abbott Laboratories

Address

6550 Singletree Dr, Columbus, Ohio 43229-1119

Distribution

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.

Timeline

Recall initiated

2005-10-07

Posted by FDA

2005-11-16

Terminated

2007-08-13

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #42363. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.