ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking
ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of the devices may leak.
What this means for you
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, and the hazard involves a potential leak in a medical device used for intravascular administration, which poses a risk of harm even though no specific injuries 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 involves 250 units of the 6" (15 cm) Smallbore Ext Set with MicroCLAVE Clear, Clamp, NanoClave T-Connector, and Rotating Luer (Item # A1003, Lot # 2773812). These devices are single-use, sterile, non-pyrogenic accessories intended for intravascular administration sets used to administer fluids to patients through a cannula placed in a vein or artery.
The recall was initiated because a small percentage of the devices may leak. The affected products were distributed worldwide, including in the United States (UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY, HI, NC) and internationally to Canada, Belgium, India, Kuwait, and Australia.
Healthcare facilities and consumers should check their inventory for the specific item and lot numbers listed above. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations. No specific instructions for end-users are provided in the source text beyond the identification of the affected lots.
The recalled product
- Product
- 6" (15 cm) Appx 0.24 ml, Smallbore Ext Set w/MicroCLAVE¿ Clear, Clamp, NanoClave¿ T-Connector, Rotating Luer, Item # A1003, Lot # 2773812. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administrat
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 250
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 # A1003
- Lot # 2773812.
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.
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