Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported October 17, 2012
Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); 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.
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 comple…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Baxter Healthcare Corp. recalled Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chambe… - a critical-severity action.
Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chambe… was recalled by Baxter Healthcare Corp. in October 17, 2012. Reason: Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function as expected,…. Check the official notice for the remedy. Verify recall #Z-0012-2013 with the FDA Devices before acting.
The recall
Baxter Healthcare Corp. issued this critical-severity FDA Devices recall-Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function as expected,….
- Critical
- severity level
- 278K units
- affected scope
- Class I
- classification
- October 17, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0012-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0012-2013) was formally reported on October 17, 2012, with the manufacturer initiating the action on September 7, 2012. It is classified under Critical severity (Class I), with a current status of Terminated. Baxter Healthcare Corp. is listed as the recalling firm, operating out of Round Lake, IL. Federal records list the affected scope as 278,420 units, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide and Internationally to Canada, Costa Rica, Australia, New Zealand, Hong Kong, and the United Kingdom.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
278,420 units
Related Recalls
6
3 from same agency
Product description
Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); 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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-0012-2013 |
| Date reported | October 17, 2012 |
| Date initiated | September 7, 2012 |
| Recalling firm | Baxter Healthcare Corp. |
| Firm location | Round Lake, IL |
| Affected scope | 278,420 units |
| Distribution | Worldwide Distribution - US Nationwide and Internationally to Canada, Costa Rica, Australia, New Zealand, Hong Kong, and the United Kingdom. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0012-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); 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.. Recalled by Baxter Healthcare Corp.. Units affected: 278,420 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 17, 2012. Severity: Critical. Recall number: Z-0012-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Nationwide and Internationally to Canada, Costa Rica, Australia, New Zealand, Hong Kong, and the United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0012-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 17, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.