ClearanceBrief
Recall Z-0570-05 ยท LZH Pump, Infusion, Enteral

Ross Products Division Abbott Laboratories

Flexiflo Quantum Enteral Pump

DateMar 8, 2005 (initiated Aug 18, 2004)
StatusTerminated
ReasonPumps were manufactured with an incorrect circuit board that may cause an increase in the feed rate and flush frequency of fluids.
Root causeOther
ActionThe firm contacted all consignees via telephone and letter on 08/18/2004.
Quantity199 individual serial numbered units
DistributionProducts were distributed to the following states nationwide: MA, NJ, NY, PA, MD, VA, NC, SC, GA, FL, CA, TN, KY, OH, MI, SD, IL, KS, LA, AR, OK, TX, and CO.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K944669FLEXIFLO QUANTUM ENTERAL PUMP
Abbott Mfg., Inc., Jul 24, 1995