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FDA Medical Device Recalls (openFDA)

Remel Inc: 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.

Recall number
Z-0808-2013
Recalling firm
Remel Inc
Product
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.
Status
Terminated
Initiated
2012-08-21
Posted
2013-02-12
Terminated
2013-06-04
Reason
The firm is recalling the product because the cartridges may contain discs that have an insufficient dose of antibiotic.
Root cause
Nonconforming Material/Component
Action
The recalling firm sent a recall notification letter dated 8/17/ 2012 and 8/21/2012.
Quantity
23 units
Distribution
US Nationwide Distribution including the states of: CA, CT, GA, IA, KS, OK, RI, TX, WA, WI,
Lot, serial or model codes
Lot 1186069
510(k) numbers
["K860153"]
PMA numbers
not on file
Product code
JTN
Firm FEI
1924669
Firm city
Lenexa
Firm state
KS
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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