Cardinal Health Prefilled Buffered 10% Formalin. Product Usage:10% NBF is used to store and fi...
FDA Device Recall #Z-0018-2015 — Class I — September 17, 2014
Recall Summary
| Recall Number | Z-0018-2015 |
| Classification | Class I — Serious risk |
| Date Initiated | September 17, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Richard-Allan Scientific Company |
| Location | Kalamazoo, MI |
| Product Type | Devices |
| Quantity | 235 cases |
Product Description
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.
Reason for Recall
The affected lots could have NBF concentrations that are lower or higher than the desired specifications.
Distribution Pattern
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.
Lot / Code Information
Product Code: C4320-450B Lot Number: 300403
Other Recalls from Richard-Allan Scientific Company
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2749-2018 | Class III | EZ Single Cytofunnel Brown, A78710004 Produc... | Jun 4, 2018 |
| Z-1895-2017 | Class II | Shandon Rapid Chrome Kwik-Diff Kit Part Number:... | Mar 15, 2017 |
| Z-2351-2016 | Class II | Richard Allan Scientific 10% Neutral Buffered F... | Jun 13, 2016 |
| Z-1319-2016 | Class III | Richard-Allan Scientific Paraffin Type 3 For i... | Feb 16, 2016 |
| Z-1639-2015 | Class II | Mucolytic Agent 1 pint/473 ml; 1 gallon/3.8 l ... | Apr 29, 2015 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.