Device product
***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.***
Z-2615-2014
Product summary
- Event
- Event 68843
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11184
- Official record key
device-enforcement:Z-2615-2014
Official wording
Reason: 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.
Code information: 2H8864- Non-DEHP Buretrol Solution Set, 150 mL CLEARLINK Burette, lots: DR13E10011 DR13E10029 DR13E11019 DR14A13013 DR14C08043
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
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.