ICU Medical Recalls 18 cm Smallbore Extension Sets Due to Leak Risk
ICU Medical is recalling 304 units of 18 cm Smallbore Extension Sets because the connection between the Female Luer and NanoClave manifold may 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 involves a medical device with a potential leak hazard that could compromise sterility or fluid delivery, representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
ICU Medical, Inc. is recalling 304 units of 18 cm (7") PUR Smallbore Extension Sets with 6-Port NanoClave Manifold, Check Valve, NanoClave, and Rotating Luer. The recall involves specific lots (3172948, 3192947, 3224228, 3246765, 3260270) and Item No. 011-AM6111.
The recall was initiated because the connection between the Female Luer and the NanoClave manifold has the potential for developing a leak. This device is a single-use, sterile, non-pyrogenic product used to provide access for the administration of fluids from a container to a patient's vascular system.
The affected units were distributed to Italy, France, and the following US states: Arizona, Ohio, Texas, and Washington. Healthcare facilities and consumers should stop using these specific lots and contact the manufacturer for further instructions.
The recalled product
- Product
- 18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, 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 sys
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — Infusion Sets
- Hazard
- Affected units
- 304
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 (5)
- Lot No. 3172948
- 3192947
- 3224228
- 3246765
- 3260270. Item No. 011-AM6111
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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