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Terminated

Oxoid Antimicrobial Susceptibility Discs, Cefoxitin 30ug REF CT0119B, packaged with 50 discs per cartridge, 5 cartridges per box. The responsible firm name on the label is Oxoid Ltd., Basingstoke, Hants, UK.

FDA Recall Z-0808-2013 · Posted 2013-02-12

Recalling FirmRemel Inc
Recall StatusTerminated
Product CodeJTN
Date Initiated2012-08-21
Date Terminated2013-06-04
Product Quantity23 units

Reason for Recall

The firm is recalling the product because the cartridges may contain discs that have an insufficient dose of antibiotic.

Firm Action

The recalling firm sent a recall notification letter dated 8/17/ 2012 and 8/21/2012.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US Nationwide Distribution including the states of: CA, CT, GA, IA, KS, OK, RI, TX, WA, WI,

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K860153OXOID ANTIMICROBIAL SUSCEPTIBILITY DISCSOxoid U.S.A., Inc. · 1986-03-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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