Z-0795-2014Class II

Oxoid Antimicrobial Susceptibility Test Discs, Ertapenem 10 mcg., CT1761B, packaged in cartridges of 50...

Name: Z-0795-2014 Oxoid Antimicrobial Susceptibility Test Discs, Ertapenem 10 mcg., CT1761B, packaged in cartridges of 50...
Creator: Remel Inc
Published: 2013-04-09
License: https://open.fda.gov/license/

Remel Inc / initiated 2013-04-09 / Terminated / root cause: manufacturing process

FDA source

Remel Inc began a recall of Oxoid Antimicrobial Susceptibility Test Discs, Ertapenem 10 mcg., CT1761B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is... on 2013-04-09. FDA classified it as Class II and gives the reason as "Cartridges may contain individual discs which were not impregnated with antibiotic". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0795-2014
Classification: Class II
Status: Terminated
Initiated: 2013-04-09
Posted: 2014-01-21
Terminated: 2014-01-21
Recalling firm: Remel Inc
Product: Oxoid 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.
Product code: JTN Susceptibility Test Discs, Antimicrobial
Reason for recall: Cartridges may contain individual discs which were not impregnated with antibiotic.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: ThermoFisher 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 commerce: 30 packs
Distribution: Nationwide Distribution: US including Puerto Rico.
Product codes and lots: Lot 1227786, Exp. 31AUG2013

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0795-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0792-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-29	2014-01-21
Z-0793-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-29	2014-01-21
Z-0794-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-29	2014-01-21
Z-0795-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-29	2014-01-21

Product code JTN

K070262Class IIErtapenem Antimicrobial Susceptibility Test DiscOxoid , Ltd. / cleared 2007-03-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)