ICU Medical Recalls Intravascular Administration Sets Due to Potential Seal Defect
ICU Medical is recalling specific lots of intravascular administration sets because a manufacturing defect may prevent a proper seal with the NanoClave 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 is classified as FDA Class II, and the hazard involves a potential seal defect in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
ICU Medical, Inc. is recalling specific lots of 113-inch (287 cm) intravascular administration sets. The recall involves 304,735 units of the product, which is a single-use, sterile, non-pyrogenic device used to administer fluids from a container to a patient's vascular system.
The recall was initiated due to a potential manufacturing defect on the internal surface of the NanoClave component within specific lots. This defect may inhibit a proper seal with the NanoClave spike. The affected product is identified by Lot Number 4734446.
The affected products were distributed worldwide, including nationwide in the United States and in several international countries such as Belgium, Brazil, Canada, France, Germany, Ireland, Japan, Martinique, Mexico, Poland, and Saudi Arabia. Healthcare facilities and consumers should stop using the affected lots and contact the manufacturer for further instructions.
The recalled product
- Product
- 113" (287 cm) Appx 14.7 ml, 10 Drop Admin Set w/MicroClave" Clear, Remv 4-Way NanoClave" Stopcock, Remv 2-Gang 4-Way NanoClave" Stopcocks, Spin Luer w/ Filter Cap, 2 Ext.1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709120171(17)250201(30)50(10)4734446. The…
- 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 (1)
- Lot Number:4734446.
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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