Recall Z-1246-2014— Remel Inc

Name: FDA recall Z-1246-2014
Creator: U.S. Food and Drug Administration
Published: 2014-02-18

Class II · Terminated

Class II FDA medical device recall by Remel Inc, initiated 2014-02-18, terminated 2014-06-25. It names one FDA 510(k) clearance: K860153. Product: Oxoid Vancomycin 30 mcg, each cartridge contains 50 susceptibility discs, CT0058B. 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.. Reason: Some of the discs may not be impregnated with the antibiotic..

Recalling firm: Remel Inc
Classification: Class II
Status: Terminated
Initiated: 2014-02-18
Terminated: 2014-06-25
Firm location: Lenexa, KS, United States

510(k) clearances named in this recall

1 on FDA's record

K860153 — OXOID ANTIMICROBIAL SUSCEPTIBILITY DISCSOxoid U.S.A., Inc.·cleared 1986-03-04

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 Vancomycin 30 mcg, each cartridge contains 50 susceptibility discs, CT0058B. 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.

Reason for recall

Some of the discs may not be impregnated with the antibiotic.

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