ICU Medical Recalls NanoClave Pressure Infusion Extension Sets Due to Seal Defect
ICU Medical is recalling specific lots of NanoClave pressure infusion extension sets because a manufacturing defect 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 involves a medical device with a defect that may inhibit a proper seal, posing a risk of harm (loss of sterility or infusion failure) 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 9.5-inch (24 cm) Smallbore Pressure Infusion Extension Sets with MicroClave and NanoClave components. 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 a potential manufacturing defect on the internal surface of the NanoClave component. This defect may inhibit a proper seal with the NanoClave spike, which could compromise the sterile fluid pathway or the delivery of fluids from an electronic or manual injector.
Healthcare facilities and distributors should identify the affected product by checking for Lot Number 4603265. The affected units are packaged as 1 unit per pouch, with 50 multivac pouches per case. Users 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 0.45 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/MicroClave, 2 NanoClave, NanoClave T-Connector, 3 Purple Clamps, Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709049496(17)250101(30)50(10)4603265. The high pressure…
- 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 (1)
- Lot Number:4603265.
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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