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U.S. Department of Health and Human Services

Class 2 Device Recall Oxoid Antimicrobial Susceptibility Test Discs, Ertapenem 10 mcg.

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 Class 2 Device Recall Oxoid Antimicrobial Susceptibility Test Discs, Ertapenem 10 mcg.see related information
Date Initiated by FirmApril 09, 2013
Date PostedJanuary 21, 2014
Recall Status1 Terminated 3 on January 21, 2014
Recall NumberZ-0795-2014
Recall Event ID 65184
510(K)NumberK070262 
Product Classification Susceptibility test discs, antimicrobial - Product Code JTN
ProductOxoid Antimicrobial Susceptibility Test Discs, Ertapenem 10 mcg., CT1761B, 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.
Code Information Lot 1227786, Exp. 31AUG2013
Recalling Firm/
Manufacturer		 Remel Inc
12076 Santa Fe Trail Dr
Lenexa KS 66215-3519
For Additional Information ContactEarleen C. Parks
913-895-4185
Manufacturer Reason
for Recall		Cartridges may contain individual discs which were not impregnated with antibiotic.
FDA Determined
Cause 2		Process design
ActionThermoFisher Scientific sent a Medical Device Recall letter dated March 22, 2013, to affected customers. Letters dated April 9, 2013, were issued for the remaining three products. Customers were instructed to notify all personnel who need to be notified and review their inventory and discard any affected product. Customers were also instructed to return the attaced Medical Device Recall Response acknowleding the dispoasl of the affected product. Customers with questions were instructed to contact the Technical Services Department at 800-255-6730 or 913-888-0939 (International). For questions regarding this recall call 913-895-4185.
Quantity in Commerce30 packs
DistributionNationwide Distribution: US including Puerto Rico.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JTN
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