Recall Z-0793-2014— Remel Inc

Name: FDA recall Z-0793-2014
Creator: U.S. Food and Drug Administration
Published: 2013-04-09

Class II · Terminated

Class II FDA medical device recall by Remel Inc, initiated 2013-04-09, terminated 2014-01-21. It names one FDA 510(k) clearance: K964491. Product: Oxoid Antimicrobial Susceptibility Test Discs, Norfloxacin 10 mcg., CT0434B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. Used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes.. Reason: Cartridges may contain individual discs which were not impregnated with antibiotic..

Recalling firm: Remel Inc
Classification: Class II
Status: Terminated
Initiated: 2013-04-09
Terminated: 2014-01-21
Firm location: Lenexa, KS, United States

510(k) clearances named in this recall

1 on FDA's record

K964491 — NORFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISCUnipath , Ltd.·cleared 1997-02-07

K-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

Oxoid Antimicrobial Susceptibility Test Discs, Norfloxacin 10 mcg., CT0434B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. Used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes.

Reason for recall

Cartridges may contain individual discs which were not impregnated with antibiotic.

Data sourced from openFDA. This site is unofficial and independent of the FDA.