ICU Medical Recalls NanoClave Connectors Due to Manufacturing Defect
ICU Medical is recalling specific lots of NanoClave Connectors because a manufacturing defect may prevent a proper seal with the spike.
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 defect that may inhibit a proper seal, posing a risk of harm to patients, but the source text does not report any specific injuries or illnesses.
Plain-English summary
ICU Medical, Inc. is recalling specific lots of NanoClave Connectors. The product is a normally closed, bidirectional connector intended for use as an accessory to an intravascular catheter placed in the vein or artery.
The recall is due to a potential manufacturing defect on the internal surface of the NanoClave. This defect may inhibit a proper seal with the NanoClave spike. The affected lots are 4549051 and 4447754.
The affected products were distributed worldwide, including in the United States and in Belgium, Brazil, Canada, France, Germany, Ireland, Japan, Martinique, Mexico, Poland, and Saudi Arabia. Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected products.
The recalled product
- Product
- NanoClave Connector; 1 unit per pouch, 100 multivac pouches per case;UDI (01)10887709051017(17)241201(30)100(10)4549051; (01)10887709051017(17)241101(30)100(10)4447754 CLAVE Neutron is a normally closed, bidirectional connector intended for use as an accessory to an…
- Manufacturer
- ICU Medical, Inc.
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 (2)
- Lot Numbers: 4549051
- 4447754.
Distribution
Part of a larger recall action
This product is one of 99 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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