Z-2614-2014Class II

BaxterBURETROL Solution Set105" (2.7 m) 150 mL BuretteDrip Chamber Filter Valve***3 Luer...

Name: Z-2614-2014 ***Baxter***BURETROL Solution Set***105" (2.7 m) 150 mL Burette***Drip Chamber Filter Valve***3 Luer...
Creator: Baxter Healthcare Corp
Published: 2014-07-14
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2014-07-14 / Terminated / root cause: manufacturing process

FDA source

Baxter Healthcare Corp began a recall of ***Baxter***BURETROL Solution Set***105" (2.7 m) 150 mL Burette***Drip Chamber Filter Valve***3 Luer Activated Valves***Male Luer Lock Adapter***with... on 2014-07-14. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2614-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-14
Posted: 2014-09-09
Terminated: 2016-03-15
Recalling firm: Baxter Healthcare Corporation
Product: ***Baxter***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.***
Product code: FPA Set, Administration, Intravascular
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Action to be taken if product was purchased directly from Baxter: Baxter is requesting that you take the following actions: 1. Locate and remove all affected product from your facility (the product code and lot number can be found on the individual product package or shipping carton). 2. Contact Baxter Healthcare Center for Service to arrange for return and credit. The Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time. Please have your Baxter eight-digit ship-to account number ready when calling. 3. Complete the enclosed customer reply form, and return it to Baxter by either fax Or scanned e-mail. 4. If you are a dealer, wholesaler, or distributor/reseller that distributed any product to other facilities, please conduct a recall with your end-user customers in accordance with your customary procedures. Baxter distributed this product to customers between September 27, 2013, and April 25, 2014. Action to be taken if the products were purshased from a distributor or re-seller. 1. Locate and remove all affected product from your facility (the product code and lot number can be found on the individual product package or shipping carton). 2. Contact Baxter Healthcare Center for Service to arrange for return and credit. The Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time. Please have your ship-to account number ready when calling. 3. Follow your supplier's reply and recall process. Please do not return the customer reply form to Baxter.
Quantity in commerce: 107232
Distribution: Nationwide Distribution.
Product codes and lots: 2C8864- Buretrol Solution Set with 150mL CLEARLINK Burette, lots: DR13E08015 DR13E08023 DR13E09013 DR13I26027 DR13I27017 DR13I27025 DR13I28015 DR13I28023 DR13J16027 DR13J17025 DR13J28022 DR13J29020 DR13K01019 DR13K20027 DR13K21025 DR13L19019 DR13L19027 DR14A11017 DR14A14011 DR14A24010 DR14A24036 DR14A31049 DR14B07054 DR14B22012 DR14B28050 DR14C01030 DR14C06013 DR14C06039

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2614-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2613-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-17	2014-09-09
Z-2614-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-17	2014-09-09
Z-2615-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-17	2014-09-09

Product code FPA

K123874Class IIInterlink System Buretrol Solution Sets, Interlink System Buretrol Solution Sets, Continued, Clearlink System Buretrol SBaxter Healthcare Corp / cleared 2013-01-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)