Class 3 Device Recall Oxoid Antimicrobial Susceptibility Test Discs, CTO425B Ciprofloxacin CIP 5 mcg.

• Date Initiated by Firm: November 21, 2012
• Date Posted: December 17, 2013
• Recall Status: Terminated on March 12, 2014
• Recall Number: Z-0528-2014
• Recall Event ID: 65734
• 510(K)Number: K860153
• Product Classification: Susceptibility test discs, antimicrobial - Product Code JTN
• 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.
• Code Information: Lot number: 1220205, exp July 21, 2015
• Recalling Firm/ Manufacturer: Remel Inc; 12076 Santa Fe Trail Dr; Lenexa KS 66215-3519
• For Additional Information Contact: Earleen C. Parks; 913-895-4185
• Manufacturer Reason for Recall: Boxes labeled as CIP5 may contain cartridges of AMP5.
• FDA Determined Cause: Mixed-up of materials/components
• Action: Thermo Fisher sent a Field Safety Notice dated November 13, 2012, to all affected customers. The letter identified the product, the problem and the action to be taken by the customer. Customers were instructed to check stocks of the affected product if necessary and contact Customer Service or their local Oxoid supplier who will issue a replacement. The notice should be passed on to all who need to be aware within their organization. Customers were also instructed to discard any product labeled as AMP5. For questions, customers were instructed to call +44 (0)1256 841144.discard any product labeled AMP5. For questions regarding this recall call 913-895-4185.
• Quantity in Commerce: 60/5/50-disc cartridge boxes
• Distribution: Nationwide Distribution including AL, CA, CO, FL, IA, KS, LA, MA, MS, NE, NH, NJ, NY, OK, OR, RI, TN, TX, VA, WA WI, and Puerto Rico.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JTN