CMS-4873 Custom CT Biopsy Tray, CMS-4873-R1 Custom CT Biopsy Tray containing 4 oz. bottle PVP Pre...
FDA Device Recall #Z-2357-2012 — Class I — September 30, 2011
Recall Summary
| Recall Number | Z-2357-2012 |
| Classification | Class I — Serious risk |
| Date Initiated | September 30, 2011 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Custom Medical Specialties, Inc. |
| Location | Pine Level, NC |
| Product Type | Devices |
| Quantity | 538 cases |
Product Description
CMS-4873 Custom CT Biopsy Tray, CMS-4873-R1 Custom CT Biopsy Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Reason for Recall
The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
Distribution Pattern
US Nationwide Distribution including the states of CO, FL, KS, MA, MI, NJ and PA.
Lot / Code Information
16661-0909, 16662-0909, 17272-0910, 17566-0911, 17566-0911, 17923-1001, 18188-1001, 18195-1001, 18793-1003, 19158-1004
Other Recalls from Custom Medical Specialties, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1234-2017 | Class II | CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray ... | Sep 20, 2016 |
| Z-0974-2014 | Class II | 5 x 93 US Probe Cover CMS-6049, Sterile, Single... | Jul 12, 2013 |
| Z-2352-2012 | Class I | CMS-8450-R1 Custom Vein Tray containing 4 oz. b... | Sep 30, 2011 |
| Z-2329-2012 | Class II | CMS-2890 Custom Needle Local Tray containing PV... | Sep 30, 2011 |
| Z-2359-2012 | Class I | CMS-5284 Custom Myelogram Tray containing 2 oz.... | Sep 30, 2011 |
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.