Baxter Interlink System Buretrol Solution Set — Class I medical device recall Z-0013-2013
Terminated recall by Baxter Healthcare Corp., reported 2012-10-17, distributed nationwide. Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function as expected,
| Recall number | Z-0013-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp., Round Lake, IL, United States |
| Recall initiated | 2012-09-07 |
| Classified | 2012-10-09 |
| Reported by FDA | 2012-10-17 |
| Terminated | 2017-12-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CR, GB, HK, NZ |
| Quantity | 1,995,040 units |
Product
Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Reason for recall
Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function as expected, allowing air to flow past the valve and into the tubing at the completion of dose within the burette.
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-0013-2013. 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.