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 4,000 units of the 10-inch (25 cm) Smallbore Extension Set with Removable MicroClave, NanoClave, Clamp, and Luer Lock (Part No. A1000, Item No. K7102-001). The affected devices are identified by Lot No. 2767371.
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 facilities and consumers should check their inventory for the specific lot number and stop using the affected devices.
The recalled product
- Product
- 10" (25 cm) Appx 0.38 ml, Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave", Clamp, Luer Lock, Part No. A1000, Item No. K7102-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 4,000
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. 2767371
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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