Baxter Recalls Microbore Catheter Extension Sets Due to Potential Leak
Baxter Healthcare Corp is recalling 23,600 units of One-Link Microbore Catheter Extension Sets due to a potential leak at the tubing to luer bond.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential leak, which poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Baxter Healthcare Corp is recalling 23,600 units of One-Link Non-DEHP Y-Type Microbore Catheter Extension Set Needle-Free IV Connector with Neutral Fluid Displacement. The recall is being conducted because of a potential for a leak at the tubing to luer bond.
The affected products are identified by Code 7N8371 and Lots UR15B16021 and UR15B23043. The distribution pattern for these units is domestic only.
The source text does not specify further instructions for consumers or healthcare providers regarding the disposal or replacement of these devices.
The recalled product
- Product
- ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLACEMENT
- Manufacturer
- Baxter Healthcare Corp
- Category
- Medical Device — IV Catheter
- Hazard
- Affected units
- 23,600
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Code: 7N8371
- Lots: UR15B16021 and UR15B23043
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Baxter Healthcare Corp
See all →- HighBaxter Amia Automated Peritoneal Dialysis Set Recalled for Flow Issues
FDA (Devices) · 2017-09-20
- ModerateBaxter Recalls Sigma Spectrum Infusion Pumps Due to Speaker Failure Risk
FDA (Devices) · 2016-12-07
- ModerateBaxter SIGMA Spectrum Infusion Pump Recall for Speaker Failure
FDA (Devices) · 2016-12-07
- ModerateBaxter Recalls SIGMA Spectrum Infusion Pump Rear Case Assemblies
FDA (Devices) · 2016-12-07
- HighBaxter Recalls Revaclear MAX Dialyzers Due to Potential Particulate Matter
FDA (Devices) · 2016-11-16
Same hazard · leak
See all →- SevereFresenius Medical Care Recalls 5008X Standard HD Pre-Flush Blood Tubing Sets
FDA (Devices) · 2026-09-09
- HighAVID Medical Recalls Halyard LAVH PACK Due to Sterilization Error
FDA (Devices) · 2026-08-26
- HighMedline Convenience Kits with Recalled Swan-Ganz Catheters
FDA (Devices) · 2026-07-08
- HighBicarby dialysate luer-lock connections may leak fluid onto floors
FDA (Devices) · 2026-06-17
- HighSwan-Ganz Pacing Catheter Model D200F7 Recall Due to Leak Risk
FDA (Devices) · 2026-05-27
Similar recalls
- HighBaxter IV Catheter Extension Set Recalled for Tubing Separation
FDA (Devices) · 2021-02-17
- ModerateBaxter Recalls Non-DEHP Y-Type Catheter Extension Set Kits
FDA (Devices) · 2013-05-15
- HighExtension IV sets recalled from one lot because the sets may leak
FDA (Devices) · 2025-10-22
- HighBaxter Recalls Non-DEHP Catheter Extension Sets Due to Sterile Barrier Compromise
FDA (Devices) · 2013-05-15
- HighBaxter Recalls Non-DEHP Y-Type Catheter Extension Sets Due to Sterility Compromise
FDA (Devices) · 2013-05-15
- HighFiltered extension sets recalled across two lots because IV sets may leak
FDA (Devices) · 2025-10-22