Recall Z-0528-2014— Remel Inc

Name: FDA recall Z-0528-2014
Creator: U.S. Food and Drug Administration
Published: 2012-11-21

Class III · Terminated

Class III FDA medical device recall by Remel Inc, initiated 2012-11-21, terminated 2014-03-12. It names one FDA 510(k) clearance: K860153. Product: Oxoid Antimicrobial Susceptibility Test Discs, CTO425B Ciprofloxacin CIP 5 mcg, 50 discs per cartridge, 5 cartridges per box. The firm name on the box label is Oxoid Ltd., Basingstoke, UK. 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: Boxes labeled as CIP5 may contain cartridges of AMP5..

Recalling firm: Remel Inc
Classification: Class III
Status: Terminated
Initiated: 2012-11-21
Terminated: 2014-03-12
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 Antimicrobial Susceptibility Test Discs, CTO425B Ciprofloxacin CIP 5 mcg, 50 discs per cartridge, 5 cartridges per box. The firm name on the box label is Oxoid Ltd., Basingstoke, UK. 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

Boxes labeled as CIP5 may contain cartridges of AMP5.

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