Recall Z-0808-2013— Remel Inc
Class II · Terminated
Class II FDA medical device recall by Remel Inc, initiated 2012-08-21, terminated 2013-06-04. It names one FDA 510(k) clearance: K860153. 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.. Reason: The firm is recalling the product because the cartridges may contain discs that have an insufficient dose of antibiotic..
- Recalling firm
- Remel Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-08-21
- Terminated
- 2013-06-04
- Firm location
- Lenexa, KS, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
The firm is recalling the product because the cartridges may contain discs that have an insufficient dose of antibiotic.
Data sourced from openFDA. This site is unofficial and independent of the FDA.