ICU Medical Recalls ChemoClave Vial Spikes Due to Plastic Burr Risk
ICU Medical is recalling certain lots of ChemoClave Vented Vial Spikes because plastic burrs from the protective cap may contaminate the device.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the assembly of the device."
Plain-English summary
ICU Medical, Inc. is recalling specific lots of the icumedical ChemoClave Vented Vial Spike (20 mm, REF CH-70S). This needle-free Closed System Transfer Device is used in IV administration sets to minimize exposure to hazardous drugs.
The recall addresses a potential issue where certain lots may contain plastic burr particulate originating from the protective cap used during device assembly. These burrs could potentially enter the system.
Affected units include 27,200 devices distributed worldwide, including in the US, Canada, France, and Singapore. The affected lot numbers are 3866759, 3872252, 3910046, and 3910627.
Users should inspect their devices for potential particulate contamination and follow standard safety protocols if any issues are found.
The recalled product
- Product
- icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-70S . Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants, including bacterial and airborne…
- Manufacturer
- ICU Medical, Inc.
- Affected units
- 27,200
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 (4)
- Lot Numbers: 3866759
- 3872252
- 3910046
- 3910627
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 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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