ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaks
ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.
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 is classified as FDA Class II. The hazard involves a potential leak in a sterile intravascular device, which poses a risk of harm (such as infection or fluid loss) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
ICU Medical, Inc. is recalling certain lots of the NanoClave Needlefree Connector product line. The recall is being conducted because a small percentage of the devices may leak.
The affected product is the 28-inch (71 cm) Smallbore Extension Set with Anti-Siphon Valve, MicroClave T-Connector, Clamp, and Rotating Luer, Item # B33071-T, Lot # 2791245. The ICU Needleless Connector is a single-use, sterile, non-pyrogenic device intended as an accessory to intravascular administration sets for administering fluids to patients through a cannula placed in a vein or artery.
The recall involves 50 units. Distribution was worldwide, including the United States (specifically UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY, HI, and NC) and internationally to Canada, Belgium, India, Kuwait, and Australia. The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled devices.
The recalled product
- Product
- 28" (71 cm) Appx 1.0 ml, Smallbore Ext Set w/Anti-Siphon Valve, MicroClave¿ T-Connector, Clamp, Rotating Luer, Item # B33071-T, Lot # 2791245. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular…
- Manufacturer
- ICU Medical, Inc.
- Hazard
- 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 (2)
- Item # B33071-T
- Lot # 2791245.
Distribution
Part of a larger recall action
This product is one of 50 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 50 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 · 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
- HighICU Medical Recalls 28 cm Smallbore Extension Sets Due to Leak Risk
FDA (Devices) · 2017-07-19
- HighICU Medical Recalls Smallbore Extension Sets Due to Potential Leak
FDA (Devices) · 2017-07-19
- HighICU Medical Recalls 10-Inch Smallbore Extension Sets Due to Leak Risk
FDA (Devices) · 2017-07-19
- HighICU Medical Recalls 18 cm Smallbore Extension Sets Due to Leak Risk
FDA (Devices) · 2017-07-19
- HighICU Medical Recalls MicroClave T-Connectors Due to Potential Leakage
FDA (Devices) · 2015-05-13
- HighICU Medical Recalls MicroClave Extension Sets Due to Leak Risk
FDA (Devices) · 2017-07-19