ICU Medical Recalls Smallbore Pressure Infusion Extension Sets
ICU Medical is recalling specific lots of smallbore pressure infusion extension sets due to a potential manufacturing defect that may inhibit 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 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 specific lots of 6.5-inch (17 cm) smallbore pressure infusion extension sets. The recall involves a total of 304,735 units distributed worldwide, including the United States and several international countries.
The recall was initiated due to the identification of a potential manufacturing defect on the internal surface of the NanoClave component within the affected sets. This defect may inhibit a proper seal with the NanoClave spike. The affected lot numbers are 4558455, 4537168, and 4493389.
Healthcare facilities and consumers should check their inventory for these specific lot numbers and stop using the affected products. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- 6.5" (17 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave, NanoClave T-Connector, Purple Clamp, Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709062525(17)250101(30)50(10)4558455…
- 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:4558455
- 4537168
- 4493389.
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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