Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer Surgical, Inc. I...
FDA Device Recall #Z-1610-2015 — Class III — April 21, 2015
Recall Summary
| Recall Number | Z-1610-2015 |
| Classification | Class III — Low risk |
| Date Initiated | April 21, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Zimmer Surgical Inc |
| Location | Dover, OH |
| Product Type | Devices |
| Quantity | 36 units |
Product Description
Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer Surgical, Inc. Intended for post-operative collection of wound drainage.
Reason for Recall
Devices were placed in a shipper carton without the appropriate number of the Instructions for Use (IFU). Packaging specifications require that each sales unit is accompanied by an IFU. Only one IFU was present in the shipper carton, instead of one IFU per each of the two sales units.
Distribution Pattern
Worldwide Distribution -- US, including the states of AZ, CA, ID, IL, MD, NC, RI, and SC; and, Canada.
Lot / Code Information
Item #00-2568-000-10; Lot #62800843
Other Recalls from Zimmer Surgical Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1202-2026 | Class II | Brand Name: Zimmer Tourniquet Systems Product ... | Dec 24, 2025 |
| Z-1201-2026 | Class II | Brand Name: Zimmer Tourniquet Systems Product ... | Dec 24, 2025 |
| Z-0924-2026 | Class II | Zimmer Air Dermatome, Model/Catalog Number: 008... | Nov 24, 2025 |
| Z-0925-2026 | Class II | Zimmer Dermatome AN, Model/Catalog Number: 8871... | Nov 24, 2025 |
| Z-1078-2024 | Class II | 3:1 Dermacarrier, Model Number 00219501300, ski... | Jan 2, 2024 |
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.