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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 7,150 units of the 7" (18 cm) Smallbore Extension Set with MicroClave Clear, NanoClave, Clamp, and Rotating Luer (Part No. A1000, Item No. A1007). These single-use, sterile, non-pyrogenic devices are intended as accessories to intravascular administration sets for administering fluids to patients through a cannula placed in a vein or artery.
The recall is being conducted because a small percentage of the devices may leak. The affected lots are 2740579, 2767063, and 2771738. The 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 these specific lot numbers. If the affected products are found, they should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- 7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave¿, Clamp, Rotating Luer, Part No. A1000, Item No. A1007 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for…
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 7,150
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. 2740579 2767063 2771738
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.
See all 50 products in this recall →Related recalls
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