ICU Medical Recalls APPX NanoClave Manifold Sets Due to Seal Defect
ICU Medical is recalling APPX 0.75 ml, 6-Port NanoClave Manifold sets because a manufacturing defect may prevent a proper seal with the spike.
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 the hazard involves a potential seal defect in a 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 APPX 0.75 ml, 6-Port NanoClave Manifold, Check Valve sets. The recall involves a total of 304,735 units distributed worldwide, including across the United States and in countries such as 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 within specific lots. This defect may inhibit a proper seal with the NanoClave spike. The affected lot numbers are 4542066, 4549203, 4558619, 4589971, 4605186, and 4733735.
The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled devices, nor does it report any illnesses or injuries associated with the defect.
The recalled product
- Product
- APPX 0.75 ml, 6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709070551(17)241201(30)50(10)4542066; (01)10887709070551(17)241201(30)50(10)4549203; (01)10887709070551(17)250101(30)50(10)4558619…
- 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 (6)
- Lot Numbers:4542066
- 4549203
- 4558619
- 4589971
- 4605186
- 4733735.
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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