CLASS II Device recall · Reported 20 Jun 2018 · FDA Enforcement Report
remel Superpack CS/ 500 Seg/Flask recalled by Thermo Fisher
Thermo Fisher is recalling remel Superpack CS/ 500 Seg/Flask, distributed nationwide in the US. The recall was initiated on 4 May 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2137-2018
- FDA event ID
- 80068
- Recalling firm
- Thermo Fisher, Lenexa, KS
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 May 2018
- FDA classified
- 8 Jun 2018
- Reported
- 20 Jun 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Bacterial Contamination
- Device type
- Other Medical Devices
Timeline
| 4 May 2018 | Recall initiated by company | |
| 8 Jun 2018 | Classified by FDA | +35 days |
| 20 Jun 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product may fail performance testing for S aureus ATCC 43300.
Product as listed by the FDA
remel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH W/OXACILLIN Product Usage: Recommended for the use in qualitative procedures to screen Staphylococcus aureus for resistance to penicillinase- resistance penicillins (e.g., methicillin, nafcillin, and oxacillin).
Where it was distributed
US Nationwide Distribution
Questions about this recall
Why was it recalled?
Product may fail performance testing for S aureus ATCC 43300.
Which lots are affected?
Lot: 307200
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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