10mm Drain Kit Flat Full Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case)...
FDA Device Recall #Z-1428-2014 — Class II — March 20, 2014
Recall Summary
| Recall Number | Z-1428-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 20, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Aspen Surgical Products, Inc. |
| Location | Caledonia, MI |
| Product Type | Devices |
| Quantity | N/A |
Product Description
10mm Drain Kit Flat Full Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
Reason for Recall
The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
Distribution Pattern
Worldwide Distribution - USA including LA, MA, NH, TX, FL, OH, NC, PA, CA, UT, TN, MI, CO, WY, OK, WA, MN, PA, IN, VA, IA, IL, MD, CT, DE, SC, NY, AR, MA, AZ, NJ, MO, GA, KS, WV, NE, NC, Puerto Rico, and Internationally to Canada, UAE, England, Italy, Belgium, Costa Rica, and Ecuador.
Lot / Code Information
Product Number 340003
Other Recalls from Aspen Surgical Products, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2390-2021 | Class II | Norton Arm Kit, Product Code 711400, (previous ... | Jul 23, 2021 |
| Z-2389-2021 | Class II | Marco Shoulder Stabilization Kit, Product Code ... | Jul 23, 2021 |
| Z-2388-2021 | Class II | Jessie Sterile Arm Suspension Kit, Product Code... | Jul 23, 2021 |
| Z-1424-2014 | Class II | 10FR Drain Kit Full Fluted with Trocar and 100m... | Mar 20, 2014 |
| Z-1423-2014 | Class II | 7mm Drain Kit Fluted 4 Channel with 100ml S-Vac... | Mar 20, 2014 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
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.