***Baxter***Buretrol Solution Set***105" — Class II medical device recall Z-2613-2014
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-2613-2014 |
|---|---|
| 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 | 234,196 |
| Lot numbers | 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 and 11 more |
Product
***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.
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-2613-2014. 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.