***Baxter***Non-DEHP***BURETROL Solution Set 105" — Class II medical device recall Z-2615-2014
Terminated recall by Baxter Healthcare Corp, reported 2014-09-17, distributed nationwide. Baxter Healthcare Corporation is voluntarily issuing a recall for specific lots of Buretrol Solution set produ
| Recall number | Z-2615-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp, Deerfield, IL, United States |
| Recall initiated | 2014-07-14 |
| Classified | 2014-09-09 |
| Reported by FDA | 2014-09-17 |
| Terminated | 2016-03-15 |
| Distributed | Nationwide (US) |
| Quantity | 11,184 |
| Lot numbers | DR13E10011, DR13E10029, DR13E11019, DR14A13013, DR14C08043 |
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.***
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2615-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.