ICU Medical Recalls Smallbore Trifuse Extension Sets Due to Seal Defect
ICU Medical is recalling specific lots of Smallbore Trifuse Extension 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 involves a risk-of-harm product (medical device) where a defect may inhibit a proper seal, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for theoretical risk without reported harm.
Plain-English summary
ICU Medical, Inc. is recalling specific lots of 5.5-inch Smallbore Trifuse Extension Sets. The recall involves 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 affected lot numbers are 4475297 and 4711598.
The recall was initiated due to a potential manufacturing defect on the internal surface of the NanoClave component within the sets. This defect may inhibit a proper seal with the NanoClave spike. The device is a single-use, sterile, non-pyrogenic intravascular administration set used to provide access for the administration of fluids from a container to a patient's vascular system.
Healthcare facilities and distributors should stop using the affected lots and contact ICU Medical for further instructions. The source text does not report any illnesses or injuries associated with this defect.
The recalled product
- Product
- 5.5" (14 cm) Appx 0.39 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, NanoClave T-Connector, 3 Clamps, Rotating Luer.1 unit per pouch, 50 multivac pouches per case. UDI: (01)10887709032153(17)241101(30)50(10)4475297; (01)10887709032153(17)250201(30)50(10)4711598. The…
- 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 (2)
- Lot Numbers:4475297
- 4711598.
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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