CLASS I Device recall · Reported 15 Oct 2014 · FDA Enforcement Report
Cardinal Health Prefilled Buffered 10% Formalin recalled
Richard-Allan Scientific is recalling Cardinal Health Prefilled Buffered 10% Formalin, distributed nationwide in the US. The recall was initiated on 17 Sep 2014 and the FDA has classified it as Class I.
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-0018-2015
- FDA event ID
- 69276
- Recalling firm
- Richard-Allan Scientific, Kalamazoo, MI
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 17 Sep 2014
- FDA classified
- 9 Oct 2014
- Reported
- 15 Oct 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Other Medical Devices
Timeline
| 17 Sep 2014 | Recall initiated by company | |
| 9 Oct 2014 | Classified by FDA | +22 days |
| 15 Oct 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The affected lots could have NBF concentrations that are lower or higher than the desired specifications.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Cardinal Health Prefilled Buffered 10% Formalin. Product Usage:10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
Where it was distributed
Worldwide Distribution-USA (nationwide) including the states of PA, IL, CA, TX, GA, WA, MA, KY, OH, NY, VA, NC, IN, NJ, MN, UT, HI, FL, KS, TN, MO, MI, MD, LA, NM, DE, CO, WV, OR, WI, AZ, SC, IA, and NE and the country of Canada.
Nationwide ArizonaCaliforniaColoradoDelawareFloridaGeorgiaHawaiiIowaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouriNorth CarolinaNebraska
Questions about this recall
Why was it recalled?
The affected lots could have NBF concentrations that are lower or higher than the desired specifications.
Which lots are affected?
Product Code: C4320-450B Lot Number: 300403
Where was it sold?
Worldwide Distribution-USA (nationwide) including the states of PA, IL, CA, TX, GA, WA, MA, KY, OH, NY, VA, NC, IN, NJ, MN, UT, HI, FL, KS, TN, MO, MI, MD, LA, NM, DE, CO, WV, OR, WI, AZ, SC, IA, and NE and the country of Canada.
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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.
Other products in this recall event
6 other products · FDA event 69276More recalls from Richard-Allan Scientific
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | EZ Single Cytofunnel Brown, A78710004 recalled | Richard-Allan Scientific | Labeling Errors | Nationwide |
| Device | CLASS II | Shandon Rapid Chrome Kwik-Diff Kit recalled by Richard-Allan Scientific | Richard-Allan Scientific | Other | 24 states |
| Device | CLASS II | Richard Allan Scientific 10% Neutral Buffered Formalin recalled | Richard-Allan Scientific | Other | 6 states |
| Device | CLASS III | Paraffin Type 3 For in vitro diagnostic use recalled | Richard-Allan Scientific | Temperature Abuse | 12 states |
| Device | CLASS II | Mucolytic Agent 1 pint recalled by Richard-Allan Scientific | Richard-Allan Scientific | Other | Nationwide |
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