ICU Medical Recalls 28 cm Bifuse Extension Sets Due to Leak Risk
ICU Medical is recalling 50 units of 28 cm Bifuse Extension Sets because the connection between the Female Luer and the NanoClave manifold may develop a leak.
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 (leak in a vascular access device) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for theoretical risk without confirmed harm.
Plain-English summary
ICU Medical, Inc. is recalling 50 units of 28 cm (11") PUR Bifuse Extension Sets with 6-Port NanoClave Manifold, Check Valve, 2 NanoClave, and Rotating Luer. The affected devices are identified by Lot No. 3303906 and Item No. 011-AM6116. These single-use, sterile, non-pyrogenic devices are used to provide access for the administration of fluids from a container to a patient's vascular system.
The recall was initiated because the connection between the Female Luer and the NanoClave manifold has the potential for developing a leak. The agency has classified this recall as Class II.
The affected units were distributed to Italy and France, as well as the following US states: Arizona, Ohio, Texas, and Washington. Healthcare facilities and consumers should stop using these specific devices and contact the manufacturer for further instructions.
The recalled product
- Product
- 28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, 2 NanoClave¿, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular syst
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — Vascular Access
- Hazard
- Affected units
- 50
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 (1)
- Lot No. 3303906. Item No. 011-AM6116
Distribution
Part of a larger recall action
This product is one of 9 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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