ICU Medical Recalls 98-inch Transfer Sets Due to Connection Separation
ICU Medical is recalling 50 units of 98-inch Transfer Sets because potential connection separation could lead to leakage.
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 risk of harm (leakage due to connection separation) where no injuries or illnesses have been reported, fitting the criteria for a High severity score.
Plain-English summary
ICU Medical, Inc. is recalling 50 units of 98" (249 cm) Transfer Sets with MicroClave T-Connectors, 2 Check Valves, Luer Lock, and Non-DEHP Tubing (Item No. B3372). The affected units are identified by Lot No. 3019521.
The recall is being issued because the MicroClave T-Connectors have potential connection separation issues that could lead to leakage. These IV administration sets are intended for the infusion and withdrawal of fluids and are provided sterile.
The affected products were distributed nationwide in the US, specifically in South Carolina, North Carolina, Minnesota, Connecticut, Kentucky, Maryland, Florida, Virginia, and Tennessee. Consumers and healthcare facilities should stop using the affected units and contact the manufacturer for further instructions.
The recalled product
- Product
- 98" (249 cm) Transfer Set w/MicroClave T-Connector, 2 Check Valves, Luer Lock, Non-DEHP Tubing, Item No. B3372 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
- Manufacturer
- ICU Medical, Inc.
- Affected units
- 50
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 (1)
- Lot No. 3019521
Distribution
Part of a larger recall action
This product is one of 8 recalled by ICU Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 8 products in this recall →Related recalls
Same manufacturer · ICU Medical, Inc.
See all →- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- ModerateICU Medical Recalls IV Administration Sets with Drip Chamber Specks
FDA (Devices) · 2026-09-23
- ModerateICU Medical Recalls Oncology Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
Same hazard · leakage
See all →- SevereDraeger VentStar Resus Neo Neonatal Breathing Circuit Recall
FDA (Devices) · 2026-10-07
- HighConvaTec Esteem Body Soft Convex Urostomy Pouches Recalled for Leakage
FDA (Devices) · 2026-08-26
- SevereStryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
FDA (Devices) · 2026-08-12
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77522
FDA (Devices) · 2026-08-05
- HighICU Medical Recalls Hotline Fluid Warming Sets Due to Leakage Risk
FDA (Devices) · 2026-07-29
Similar recalls
- HighICU Medical Recalls IV Administration Sets with ChemoLock Port Leak Risk
FDA (Devices) · 2016-04-06
- HighICU Medical Bifuse Transfer Set Recalled Due to Missing Blood Filter
FDA (Devices) · 2018-10-10
- HighICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking
FDA (Devices) · 2014-01-15
- HighICU Medical Recalls I.V. Infusion Sets with Potential Leak
FDA (Devices) · 2016-04-06
- HighICU Medical Recalls ChemoLock IV Administration Sets Due to Leak Risk
FDA (Devices) · 2016-04-06
- HighICU Medical Recalls IV Infusion Sets with Potential ChemoLock Port Leak
FDA (Devices) · 2016-04-06