Home / Recalls / Baxter Healthcare Corp / Z-2613-2014

Z-2613-2014 Class II Terminated

Recalled by Baxter Healthcare Corp — Deerfield, IL

FDA device recall Z-2613-2014 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: 234196.

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
234196

Product Description

***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.***

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

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

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-2613-2014
openFDA file date
Oct 27, 2026
Loaded by RegDataLab
Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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FDA data resources