***Baxter***BURETROL Solution Set***105" (2.7 m) 150 mL Burette***Drip Chamber Filter Valve***3 ...
FDA Device Recall #Z-2614-2014 — Class II — July 14, 2014
Recall Summary
| Recall Number | Z-2614-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 14, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Baxter Healthcare Corp |
| Location | Deerfield, IL |
| Product Type | Devices |
| Quantity | 107232 |
Product Description
***Baxter***BURETROL Solution Set***105" (2.7 m) 150 mL Burette***Drip Chamber Filter Valve***3 Luer Activated Valves***Male Luer Lock Adapter***with Retractable Collar***Fluid path is Sterile, Nonpyrogenic. ****Indications for Use: For the administration of fluids from a container into the patient's vascular system through a vascular access device.***
Reason for Recall
Baxter Healthcare Corporation is voluntarily issuing a recall for specific lots of Buretrol Solution set product codes due to complaints for separation between the burette chamber and the drip chamber. Affected product codes are: 2C7564, 2C8864 and 2H8864.
Distribution Pattern
Nationwide Distribution.
Lot / Code Information
2C8864- Buretrol Solution Set with 150mL CLEARLINK Burette, lots: DR13E08015 DR13E08023 DR13E09013 DR13I26027 DR13I27017 DR13I27025 DR13I28015 DR13I28023 DR13J16027 DR13J17025 DR13J28022 DR13J29020 DR13K01019 DR13K20027 DR13K21025 DR13L19019 DR13L19027 DR14A11017 DR14A14011 DR14A24010 DR14A24036 DR14A31049 DR14B07054 DR14B22012 DR14B28050 DR14C01030 DR14C06013 DR14C06039
Other Recalls from Baxter Healthcare Corp
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-3133-2017 | Class II | Baxter Amia Automated Peritoneal Dialysis Set w... | Sep 1, 2017 |
| Z-1839-2016 | Class II | COSEAL Surgical Sealant Kit, 4 mL, Product Code... | May 12, 2016 |
| Z-1840-2016 | Class II | COSEAL Surgical Sealant Kit, 8 mL, Product Code... | May 12, 2016 |
| Z-1838-2016 | Class II | COSEAL Surgical Sealant Kit, 2 mL, Product Code... | May 12, 2016 |
| Z-0132-2016 | Class II | ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXT... | May 21, 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.