ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking
ICU Medical is recalling NanoClave Needlefree Connectors because a small percentage of devices may leak. The affected units were distributed worldwide.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is Class II, which corresponds to a Severe rating under the rubric for medical devices with potential for serious adverse health consequences.
Plain-English summary
ICU Medical, Inc. is recalling certain lots of the NanoClave Needlefree Connector product line. The recall is being conducted because a small percentage of the devices may leak. The specific product involved is the 7" (18 cm) Appx 0.26 ml, Smallbore Ext Set w/MicroClave Clear, NThe ICU Needleless Connector, Part No. A1000, Item No. K7089-001.
The affected units are identified by Lot No. 2784699. The recall covers 500 units that were distributed worldwide, including in the United States (UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY, HI, NC) and internationally to Canada, Belgium, India, Kuwait, and Australia.
This is a Class II recall. The devices are single-use, sterile, non-pyrogenic accessories intended for intravascular administration sets. Users should stop using the affected lots and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- 7" (18 cm) Appx 0.26 ml, Smallbore Ext Set w/MicroClave¿ Clear, NThe ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula…
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 500
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. 2784699
Distribution
Part of a larger recall action
This product is one of 50 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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