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. The hazard involves a potential leak in a medical device used for intravascular administration, which presents a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
ICU Medical 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 8" (20 cm) Appx 0.49 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock, Part No. A1000, Item No. A1069. 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 2773045.
The recall involves 50 units. Distribution was worldwide, including the USA (UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY, HI, NC) and internationally to CA, BE, IN, KW, and AU. The source text does not specify instructions for consumers or healthcare providers regarding the handling of these devices.
The recalled product
- Product
- 8" (20 cm) Appx 0.49 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock, Part No. A1000, Item No. A1069 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the adminis
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 50
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. 2773045
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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