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 'High' severity criteria for risk-of-harm products 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 700 units of the 6-inch (15 cm) Smallbore Extension Set with Clamp, NanoClave TConnector, and Rotating Luer (Part No. A1000, Item No. A1001). The affected lot numbers are 2773810, 2777115, and 2781555.
The recall was initiated because a small percentage of the devices may leak. These single-use, sterile, non-pyrogenic devices are intended as accessories to intravascular administration sets for the administration of fluids to patients through a cannula placed in a vein or artery.
The affected products 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 lots and contact ICU Medical for further instructions.
The recalled product
- Product
- 6" (15 cm) Appx 0.26 ml, Smallbore Ext Set w/Clamp, NanoClave¿ TConnector, Rotating Luer, Part No. A1000, Item No. A1001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the admi
- Manufacturer
- ICU Medical, Inc.
- Affected units
- 700
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. 2773810 2777115 2781555
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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