ICU Medical Recalls Smallbore Extension Sets Due to Seal Defect
ICU Medical is recalling specific lots of 6-inch smallbore extension sets because a manufacturing defect may prevent the NanoClave from sealing properly.
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 involves a risk-of-harm product (intravascular device) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
ICU Medical, Inc. is recalling 304,735 units of 6-inch (15 cm) smallbore extension sets with MicroClave Clear, Clamp, NanoClave T-Connector, and Rotating Luer. The recall affects lot numbers 4605103 and 4733543. These devices are single-use, sterile, non-pyrogenic intravascular administration sets used to provide access for the administration of 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. This defect may inhibit a proper seal with the NanoClave spike. The agency classifies this as a Class II recall.
The affected products were distributed worldwide, including nationwide in the United States and in Belgium, Brazil, Canada, France, Germany, Ireland, Japan, Martinique, Mexico, Poland, and Saudi Arabia. Healthcare facilities and users should stop using the affected lots and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- 6" (15 cm) Appx 0.24 ml, Smallbore Ext Set w/MicroClave Clear, Clamp, NanoClave T-Connector, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case; UDI: (01)10887709051031(17)250101(30)50(10)4605103;(01)10887709051031(17)250201(30)50(10)4733543 The Intravascular…
- 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: 4605103
- 4733543.
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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