ICU Medical Recalls Smallbore Quadfuse Extension Sets Due to Seal Defect
ICU Medical is recalling specific lots of Smallbore Quadfuse 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 involves a risk-of-harm product where injury has not yet been reported, meeting the criteria for a High severity score.
Plain-English summary
ICU Medical, Inc. is recalling specific lots of 15 cm Smallbore Quadfuse Extension Sets with 4 NanoClave 3 BCV RLL. 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. The affected products are identified by lot numbers 4735112 and 4493240.
Healthcare facilities and consumers should stop using the affected products and contact ICU Medical for further instructions or a return.
The recalled product
- Product
- 15 cm (6 IN) Appx 1.1 ml, Smallbore Quadfuse Ext Set w/4 NanoClave 3 BCV RLL.1 unit per pouch, 50 pouches per case. UDI:(01)10840619076174(17)250201(30)50(10)4735112; (01)10840619076174(17)241201(30)50(10)4493240. Administration sets and their accessories are single use, pre
- 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:4735112
- 4493240.
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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