Z-2614-2014 Class II Terminated
FDA device recall Z-2614-2014 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: 107232.
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
- 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.
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2614-2014
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026