FDAFDA · Food and drugs·Recall number Z-2613-2014
***Baxter***Buretrol Solution Set***105" (2.7 m)***150 mL Burette***Drip Chamber Filter Valve***3 Injection Sites 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.***
Published September 17, 2014 · Recall initiated: July 14, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Baxter Healthcare Corp
- Distributor
- Nationwide Distribution.
- Lot
- 2C7564- Buretrol Solution Set with 150mL INTERLINK Burette, lots: DR13E06019 DR13E07017 DR13E07025 DR13I14023 DR13I16010 DR13I16028 DR13I23016 DR13I23024 DR13J03033 DR13J04015 DR13J04023 DR13J08024 DR13J09014 DR13J09022 DR13J24021 DR13J24039 DR13K07024 DR13K08022 DR13K12024 DR13K13022 DR13K18021 DR13K19029 DR13K25026 DR13K26024 DR13L02023 DR13L03039 DR13L10018 DR13L11016 DR13L18011 DR13L18029 DR13L19035 DR14A09052 DR14A10035 DR14A23012 DR14A23020 DR14A29027 DR14A30017 DR14B06049 DR14B07013 DR14B07047 DR14B11023 DR14B13037 DR14B13045 DR14B14019 DR14B20016 DR14B20032 DR14B21014 DR14B26013 DR14B26039 DR14C05015 DR14C05031
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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