Cardiac Insulation Pad, OPEN HEART CDS
FDA Device Recall #Z-2979-2018 — Class II — April 12, 2017
Recall Summary
| Recall Number | Z-2979-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 12, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medline Industries, Inc. |
| Location | Waukegan, IL |
| Product Type | Devices |
| Quantity | 77 kits |
Product Description
Cardiac Insulation Pad, OPEN HEART CDS
Reason for Recall
Complete delivery System (CDS) # CDS984746C was assembled using a non-sterile cardiac insulation pad, Medline component number 32369. The non-sterile component (32369) was placed within the non-sterile portion of the CDS assembly. This component should have been placed inside the sterile portion of the pack where it would have subsequently been exposed to an ethylene oxide sterilization process. This component was not placed in the sterile portion of the pack and was not sterilized, resulting in the inadvertent release of this item in a non-sterile state. The contents of the sterile kit were properly sterilized and the remaining contents of the non-sterile subassembly had the appropriate sterility status based on their intended use.
Distribution Pattern
CA, NM
Lot / Code Information
Model: CDS984745C; Lots: 17GD0936, 17FD1655, 17ED3419, 17ED1482, 17ED0636, 17DD0666, 17DD0296, 17AD1912, 16LD3005, 16LD0059, 16JD3201, 16ID3179, 16HD1298, 16GD0779, 16FD3925, 16CD0303 and 16AD4032
Other Recalls from Medline Industries, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1984-2019 | Class II | Anti-fog solution packaged in a Tyvek peel pouc... | May 30, 2019 |
| Z-2378-2018 | Class II | BARD MYPICC Kit, REF CK000095B, 5F French Size,... | Jan 12, 2018 |
| Z-2978-2018 | Class II | Laparoscopy CDS | Apr 12, 2017 |
| Z-2976-2018 | Class II | Art-Line Surgery Pack-LF, STERILE, 40 packs eac... | Apr 12, 2017 |
| Z-2980-2018 | Class II | LASER CDS | Apr 12, 2017 |
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.