Device recall: Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid…

Class I FDA enforcement event 63059. Recall start date: 7 Sep 2012. Status in the FDA record: Terminated. Termination date: 29 Dec 2017.

Reason for recall, in the words of FDA

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.

Class I, in the words of FDA

a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death

Baxter Healthcare Corp. started this device recall on 7 Sep 2012. The firm address in the FDA record is in Round Lake, IL. FDA put the recall in Class I. FDA event 63059 has 4 product records. The first FDA enforcement report date is 17 Oct 2012. The record gives the status Terminated, with the termination date 29 Dec 2017.

FDA enforcement report The 4 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide Distribution - US Nationwide and Internationally to Canada, Costa Rica, Australia, New Zealand, Hong Kong, and the United Kingdom.

Recalling firm

Baxter Healthcare Corp., Round Lake, IL.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

4 product records in the event.

FDA event 63059: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0012-2013	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.	278,420 units	Class I	Terminated	17 Oct 2012
Z-0013-2013	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.	1,995,040 units	Class I	Terminated	17 Oct 2012
Z-0014-2013	Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clearlink 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.	2,265,453 units	Class I	Terminated	17 Oct 2012
Z-0015-2013	Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clearlink 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.	488,504 units	Class I	Terminated	17 Oct 2012

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class I: The highest of the three FDA recall classes.

The event in context

Device events that started in 2012: 823
Share of these events in Class I: 5%
Product records in this event: 4Median of the firm: 1
Events of the firm on the register: 83

Other events of the firm

Other FDA enforcement events of Baxter Healthcare Corp.
Initiated	Product (first record)	Type	Class	Records
1 Sep 2017	Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479	Device	Class II	1
12 Oct 2016	GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634 Product Usage: The Revaclear Max dial	Device	Class II	1
28 Sep 2016	sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 Spectrum Infusion Pump, Product Code 35700BAX and 3	Device	Class II	3
24 Jun 2016	Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1 cm x 6 cm, product code VG0106	Device	Class II	1
23 May 2016	PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy	Device	Class II	1
12 May 2016	COSEAL Surgical Sealant Kit, 2 mL, Product Code: 934070; For use in vascular reconstructions to achieve adjunctive hemos	Device	Class II	3
21 Apr 2016	GEM(TM), FLOWCOUPLER(R), 2.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2752-FC Product Usage: The FlowCOUPLER Devic	Device	Class II	5
12 Apr 2016	Brevibloc DOUBLE STRENGTH Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2000mg/100mL (20 mg/mL), 100 mL,	Drug	Class II	1
16 Feb 2016	Automated peritoneal dialysis (APD) cycler	Device	Class II	1
5 Feb 2016	0.9% Sodium Chloride Irrigation, USP, 500 mL bottle, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, Produc	Drug	Class II	1

Baxter Healthcare Corp.: all 83 events

Official channels

FDA enforcement report Z-0012-2013The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 63059. https://recallregister.com/fda/i/63059/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide Distribution - US Nationwide and Internationally to Canada, Costa Rica, Australia, New Zealand, Hong Kong, and the United Kingdom.
What quantity of product is in FDA event 63059?: The event has 4 product records. The first record gives this quantity: 278,420 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2012 have the same class?: 5% of the 823 device events that started in 2012 are in Class I.