ICU Medical Recalls Smallbore Extension Sets Due to Seal Defect
ICU Medical is recalling specific lots of 5.5-inch smallbore extension sets because a manufacturing defect may prevent the NanoClave spike from sealing properly.
What this means for you
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 specific lots of 5.5-inch (14 cm) smallbore extension sets with NanoClave, clamp, and Luer Lock. The recall involves a total of 304,735 units distributed nationwide in the United States and in several countries including Belgium, Brazil, Canada, France, Germany, Ireland, Japan, Martinique, Mexico, Poland, and Saudi Arabia.
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 affected product is a single-use, sterile, non-pyrogenic device used to provide access for the administration of fluids from a container to a patient's vascular system.
The affected lot numbers are 4603285, 4630700, 4749870, 4514843, 4549093, 4558478, 4724850, and 4734400. Healthcare facilities and distributors should check their inventory for these specific lot numbers and stop using the affected products. Consumers who have purchased these products should contact the manufacturer for instructions on how to proceed.
The recalled product
- Product
- 5.5" (14 cm) Appx 0.28 ml, Smallbore Ext Set w/NanoClave, Clamp, Luer Lock. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709077758(17)250101(30)50(10)4603285;(01)10887709077758(17)250101(30)50(10)4603285; (01)10887709077758(17)250101(30)50(10)4630700; (01)108877
- 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 (8)
- Lot Numbers:4603285
- 4630700
- 4749870
- 4514843
- 4549093
- 4558478
- 4724850
- 4734400.
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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