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.
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. The hazard involves a medical device that may leak, which poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
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 7" (18 cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave Clear, NanoClave T-Connector, Clamp, Rotating Luer, Part No. A1000, Item No. K7090-001. This is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration sets for the administration of fluids to a patient through a cannula placed in the vein or artery. The specific lot number affected is 2767361.
The recall involves 4,000 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. Healthcare facilities and consumers should stop using the affected devices and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- 7" (18 cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave" T-Connector, Clamp, Rotating Luer, Part No. A1000, Item No. K7090-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular a
- 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. 2767361
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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