ICU Medical Recalls Smallbore Pressure Infusion Extension Sets Due to Seal Defect
ICU Medical is recalling specific lots of smallbore pressure infusion 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 (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
ICU Medical, Inc. is recalling specific lots of 7-inch smallbore pressure infusion extension sets. The recall involves units with UDI codes (01)10887709088190 and (01)10887709068350, corresponding to lot numbers 4515232 and 4572761. These devices are used as conduit tubing to deliver fluids from electronic or manual injectors and to provide a sterile fluid pathway between devices.
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 has classified this recall as Class II.
The affected products were distributed worldwide, including nationwide in the United States and in countries such as Belgium, Brazil, Canada, France, Germany, Ireland, Japan, Martinique, Mexico, Poland, and Saudi Arabia. Healthcare facilities and consumers should check their inventory for the specific lot numbers and UDI codes listed above. If the affected products are found, they should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- 7" (18 cm) Appx 0.31 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave Clear, Clamp, NanoClave T-Connector (Purple Ring), Rotating Luer; unit per pouch, 50 multivac pouches per case.…
- 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 (2)
- Lot Numbers:4515232
- 4572761.
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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