ICU Medical Recalls NanoClave Administration Sets Due to Seal Defect
ICU Medical is recalling specific lots of NanoClave administration sets due to a manufacturing defect that may prevent a proper seal.
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 risk-of-harm product (improper seal) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
ICU Medical, Inc. is recalling specific lots of 11-inch NanoClave administration sets. The recall is due to a potential manufacturing defect on the internal surface of the NanoClave component, which may inhibit a proper seal with the NanoClave spike.
The affected products are single-use, pre-sterilized devices used to administer fluids to patients. The recall covers a total of 304,735 units distributed worldwide, including in the United States and several international countries. The specific lot numbers involved are 4718517, 4514500, and 4727354.
Healthcare providers and facilities should stop using the affected lots and contact ICU Medical for further instructions. Consumers are advised to check their medical records or consult their healthcare provider if they have received these specific products.
The recalled product
- Product
- 11 IN(28cm)APPX 0.7ml,SMALLBORE, 2 NanoClave, Filter. 1 unit per pouch, 50 pouches per case. UDI: ¿(01)10840619059801(17)250201(30)50(10)4718517; (01)10840619059801(17)241201(30)50(10)4514500; (01)10840619059801(17)250201(30)50(10)4727354. Administration sets and their…
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — Infusion Sets
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)
- Lot Numbers:4718517
- 4514500
- 4727354.
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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