Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Oxoid Antimicrobial Susceptibility Testing Disc, MEM10, REF: CT0774B, 10 mcg meropenem

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Oxoid Antimicrobial Susceptibility Testing Disc, MEM10, REF: CT0774B, 10 mcg meropenem see related information
Date Initiated by Firm November 21, 2013
Date Posted January 14, 2014
Recall Status1 Terminated 3 on December 11, 2014
Recall Number Z-0734-2014
Recall Event ID 67099
510(K)Number K983718  
Product Classification Susceptibility test discs, antimicrobial - Product Code JTN
Product Oxoid Antimicrobial Susceptibility Testing Disc, MEM10, REF: CT0774B, 10 mcg meropenem, Packed in packs containing 5 cartridges per pack, 50 discs per cartridge. Firm name on the label is Oxoid, Ltd., Basingstoke, United Kingdom.

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: 1223566 EXP: 8/31/2013
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		 Individual discs in the lot may not be sufficiently impregnated with antibiotic, resulting in smaller than expected zone sizes.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action Oxoid and Remel part of Thermo Fisher Scientific sent an Urgent Medical Device Recall letter dated November 20, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. The letter asked customers to destroy the affected product, if any was found on hand. The letter also asked if the customer further distributed the product that they inform their downstream customers. A response form was included with the letter and the letter instructed customers to complete and return the response form to indicate they had received the notification and that they had complied with it. If you have any questions please contact our Technical Service Department at 800-255-6730 (US) or 913-888-0939 (International).
Quantity in Commerce 45/5/50 - discs/cartridges/packs
Distribution Nationwide Distribution including the states of AL, AZ, CA, CO, FL, HI, IA, IL, KY, LA, MD, MI, MN, MO, MS, NC, NY, OH, SC, TN, TX, VA, WI, and WV
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 and Original Applicant = OXOID, LTD.
-
-