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Terminated

Flexiflo Quantum Enteral Pump

FDA Recall Z-0570-05 · Posted 2005-03-08

Recalling FirmRoss Products Division Abbott Laboratories
Recall StatusTerminated
Product CodeLZH
Date Initiated2004-08-18
Date Terminated2012-04-12
Product Quantity199 individual serial numbered units

Reason for Recall

Pumps were manufactured with an incorrect circuit board that may cause an increase in the feed rate and flush frequency of fluids.

Firm Action

The firm contacted all consignees via telephone and letter on 08/18/2004.

Root Cause

Other

Distribution Pattern

Products 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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K944669FLEXIFLO QUANTUM ENTERAL PUMPAbbott Mfg., Inc. · 1995-07-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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