FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corp.: 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
- Recall number
- Z-0070-2011
- Recalling firm
- Baxter Healthcare Corp.
- 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
- Status
- Terminated
- Initiated
- 2010-09-03
- Posted
- 2010-10-15
- Terminated
- 2011-02-25
- Reason
- 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
- 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
- 948 units
- Distribution
- Nationwide distribution: Wisconsin only.
- Lot, serial or model codes
- product code 3C0166, lot GR288365
- 510(k) numbers
- ["K984381"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 1416980
- Firm city
- Round Lake
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28