Z-2613-2014Class II

BaxterBuretrol Solution Set105" (2.7 m)150 mL BuretteDrip Chamber Filter Valve3 Injection...

Name: Z-2613-2014 ***Baxter***Buretrol Solution Set***105" (2.7 m)***150 mL Burette***Drip Chamber Filter Valve***3 Injection...
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 Injection Sites Male Luer Lock Adapter with***Retractable... 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-2613-2014
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 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.***
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: 234196
Distribution: Nationwide Distribution.
Product codes and lots: 2C7564- Buretrol Solution Set with 150mL INTERLINK Burette, lots: 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 DR14B11023 DR14B13037 DR14B13045 DR14B14019 DR14B20016 DR14B20032 DR14B21014 DR14B26013 DR14B26039 DR14C05015 DR14C05031

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2613-2014
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)