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 criteria for a risk-of-harm product 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 the 184 cm (72") Smallbore Bifuse Ext Set with 2 NanoClave, 2 Anti-Syphon Valves, 0.2 Micron Positive Filter, BCV-Clave, NanoClave TConnector, and Rotating Luer (Part No. A1000, Item No. 011-A1095). The affected lots are 2776972, 2785650, and 2796669.
The recall is being conducted because a small percentage of the devices may leak. The product 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 recall involves 250 units. Distribution was worldwide, including 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. The source text does not specify instructions for consumers or healthcare providers regarding the disposition of the recalled units.
The recalled product
- Product
- 184 cm (72") Smallbore Bifuse Ext Set w/2 NanoClave¿, 2 Anti-Syphon Valves, 0.2 Micron Positive Filter, BCV-Clave¿, NanoClave¿ TConnector, Rotating Luer, Part No. A1000, Item No. 011-A1095 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended…
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — Infusion Sets
- Hazard
- Affected units
- 250
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 (3)
- Item No. 011-A1095. Lot No. 2776972
- 2785650
- 2796669.
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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