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 is classified as FDA Class II, and the hazard involves a medical device that may leak, posing a risk of harm to patients without reported injuries or illnesses.
Plain-English summary
ICU Medical, Inc. 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 NanoClave Connector, identified by Part No. A1000 and Item Nos. 011-A1000, 061-A1000, A1000, K7083-001, and Z3769. This single-use, sterile, non-pyrogenic device is intended as an accessory to intravascular administration sets for administering fluids to patients through a cannula placed in a vein or artery.
The recall involves 69,100 units distributed worldwide, including in the United States and internationally to Canada, Belgium, India, Kuwait, and Australia. Specific lot numbers affected include 2766916, 2781527, 2776455, 2767054, 2768331, 2770578, 2781554, 2785375, 2767355, 2783362, 2787992, and 34-463-HE.
The recalled product
- Product
- NanoClave Connector, Part No. A1000, Item No. 011-A1000, 061-A1000, A1000, K7083-001, Z3769 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a…
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 69,100
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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