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 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 potential leak in a medical device used for intravascular administration, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
ICU Medical, Inc. is recalling certain lots of the NanoClave Needlefree Connector product line. The recall involves the 6" (15 cm) Smallbore Ext Set with Clamp, NanoClave TConnector, and Rotating Luer, identified by Part No. A1000 and Item No. K7084-001. The affected lot number is 2767356.
The recall is being conducted because a small percentage of the devices may leak. These devices are single-use, sterile, non-pyrogenic accessories intended for intravascular administration sets to deliver fluids to patients through a cannula placed in a vein or artery.
Approximately 4,000 units 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 stop using the affected devices and contact ICU Medical for instructions on return or replacement.
The recalled product
- Product
- 6" (15 cm) Appx 0.27 ml, Smallbore Ext Set w/Clamp, NanoClave" TConnector, Rotating Luer, Part No. A1000, Item No. K7084-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the
- 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. 2767356
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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