ICU Medical Recalls NanoClave Needleless Connectors Due to Potential Leaking
ICU Medical is recalling specific lots of NanoClave Needleless 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 involves a medical device with a functional defect (leaking) that poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
ICU Medical, Inc. is recalling certain lots of the NanoClave Needlefree Connector product line. The recall involves 10,400 units of the 7" (18cm) Smallbore Extension Set with Removable MicroCLAVE Clear, NanoClave T-Connector, Clamp, and Rotating Luer (Part No. A1000, Item No. A1009). The affected lot numbers are 2770580, 2774284, 2777867, 2781557, and 2782915.
The recall was initiated because a small percentage of the devices may leak. The NanoClave Needleless Connector is a single-use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration sets for administering fluids to patients through a cannula placed in a vein or artery.
The affected products were distributed worldwide, including in the United States (specifically UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY, and HI) and internationally to Canada, Belgium, India, Kuwait, and Australia. Healthcare providers and consumers should check their inventory for these specific lot numbers and stop using the affected devices.
The recalled product
- Product
- 7" (18cm) Appx 0.32 ml, Smallbore Ext Set w/Remv MicroCLAVE¿ Clear, NanoClave¿ T-Connector, Clamp, Rotating Luer, Part No. A1000, Item No. A1009 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular adminis
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 10,400
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. 2770580 2774284 2777867 2781557 2782915
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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