Z-2615-2014 Class II Terminated
FDA device recall Z-2615-2014 was initiated by Baxter Healthcare Corp on Jul 14, 2014 and is designated Class II. 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… The recall status is terminated (terminated Mar 15, 2016). Affected quantity: 11184.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 17, 2014
- Initiation Date
- Jul 14, 2014
- Termination Date
- Mar 15, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11184
Product Description
***Baxter***Non-DEHP***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.
Code Information
2H8864- Non-DEHP Buretrol Solution Set, 150 mL CLEARLINK Burette, lots: DR13E10011 DR13E10029 DR13E11019 DR14A13013 DR14C08043
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2615-2014
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026