Z-0070-2011

Baxter Interlink System Buretrol Solution Set, 83" (2.1 m), 150 mL Burette Drip Chamber Filter Valve, 2...

Name: Z-0070-2011 Baxter Interlink System Buretrol Solution Set, 83" (2.1 m), 150 mL Burette Drip Chamber Filter Valve, 2...
Creator: Baxter Healthcare Corp.
Published: 2010-09-03
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2010-09-03 / Terminated / root cause: manufacturing process

FDA source

Baxter Healthcare Corp. began a recall of Baxter Interlink System Buretrol Solution Set, 83" (2.1 m), 150 mL Burette Drip Chamber Filter Valve, 2 Injection Sites, Male Luer Lock Adapter, Large Bore... on 2010-09-03. The reason FDA records is "There are leaks in the Drip Chamber Check Valve Subassembly of the Solution Set. A leak in a sterile pathway could allow microbial entry, which could lead to a blood stream infection". 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-0070-2011
Status: Terminated
Initiated: 2010-09-03
Posted: 2010-10-15
Terminated: 2011-02-25
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Interlink System Buretrol Solution Set, 83" (2.1 m), 150 mL Burette Drip Chamber Filter Valve, 2 Injection Sites, Male Luer Lock Adapter, Large Bore 4-Way Stopcock with Rotating Male Luer Lock Extension Set, 38" (97 cm), Vol. 5.8 mL, Injection Site, Male Luer Lock Adapter, 60 DPM; a sterile Rx IV fluid pathway device; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 3C0166 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: There are leaks in the Drip Chamber Check Valve Subassembly of the Solution Set. A leak in a sterile pathway could allow microbial entry, which could lead to a blood stream infection.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Baxter sent an "Urgent Product Recall" letter dated September 2, 2010, via first class mail to the direct account, to the attention of the Director of Materials Management, with a copy sent to the Director of Nursing, on the same date, informing them that leaks were detected in the Drip Chamber Check Valve Subassembly used in the affected lot of Interlink System Buretrol Solution Sets. A leak in a sterile pathway could allow microbial entry, which could lead to a blood stream infection. The account was requested to examine their inventory in all locations to determine if they have any of the affected lot and remove the affected product from inventory; call Baxter Healthcare Center for Service at 1-888-229-0001 to return the affected product, request a credit, or request replacement product; complete the attached customer reply form confirming their receipt of the letter and fax it to Baxter at the number provided on the form. Dealers, wholesalers and distributors were requested to notify their customers of this action so they can comply with the procedures listed above. Any questions regarding the communication were directed to The Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm CST.
Quantity in commerce: 948 units
Distribution: Nationwide distribution: Wisconsin only.
Product codes and lots: product code 3C0166, lot GR288365

Product code FPA

K984381Class IIBuretrol Solution SetsBaxter Healthcare Corp / cleared 1999-02-19

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)