ICU Medical Recalls Intravascular Administration Sets Due to Seal Defect
ICU Medical is recalling specific lots of intravascular administration 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. The hazard involves a potential seal defect in a medical device used for intravascular administration, which poses a risk of harm (such as fluid leakage or contamination) even though specific injuries are not reported in the source text.
Plain-English summary
ICU Medical, Inc. is recalling specific lots of 99-inch intravascular administration sets. The recall involves a potential manufacturing defect on the internal surface of the NanoClave component within these sets. This defect may inhibit a proper seal with the NanoClave spike.
The affected product is a single-use, sterile, non-pyrogenic device used to provide access for the administration of fluids from a container to a patient's vascular system. The recall covers a total of 304,735 units across two specific lot numbers: 4515251 and 4537242.
The products were distributed worldwide, including nationwide in the United States and in countries such as Belgium, Brazil, Canada, France, Germany, Ireland, Japan, Martinique, Mexico, Poland, and Saudi Arabia. Healthcare facilities and distributors should stop using the affected lots and contact the manufacturer for further instructions.
The recalled product
- Product
- 99 IN (251cm) APPX 12.6ml, 20 Drop, 2 Clave, 2 NanoClave 4-Way Stopcocks, Drop-In Ext, Clave; 1 unit per pouch, 25 pouches per case. UDI: (01)10887709066318(17)241201(30)25(10)4515251; (01)10887709066318(17)241201(30)25(10)4537242. The Intravascular Administration Set is a si
- Manufacturer
- ICU Medical, Inc.
- Hazard
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:4515251
- 4537242.
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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