ICU Medical Recalls Smallbore Intravascular Administration Sets Due to Seal Defect
ICU Medical is recalling specific lots of smallbore intravascular administration sets because a manufacturing defect may prevent the NanoClave spike 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 the hazard involves a risk-of-harm product (medical 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 9.5-inch (24 cm) smallbore intravascular administration sets. These single-use, sterile devices are used to administer fluids from a container to a patient's vascular system. The recall affects Lot Number 4603290, which has a UDI of (01)10887709080703(17)250101(30)50(10)4603290.
The recall was initiated due to a potential manufacturing defect on the internal surface of the NanoClave component within the affected lots. This defect may inhibit a proper seal with the NanoClave spike. The agency has classified this as a Class II recall.
The affected products were distributed nationwide in the United States and in several countries including Belgium, Brazil, Canada, France, Germany, Ireland, Japan, Martinique, Mexico, Poland, and Saudi Arabia. Healthcare facilities and distributors should stop using the affected lots and contact ICU Medical for instructions on return or replacement.
The recalled product
- Product
- 9.5" (24 cm) Appx 0.56 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Luer Lock; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709080703(17)250101(30)50(10)4603290. The Intravascular Administration Set is a single use, sterile, non-pyrogenic…
- 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:4603290.
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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