ICU Medical Recalls ChemoClave Vial Spikes Due to Plastic Particulate
ICU Medical is recalling specific lots of ChemoClave Vial Spikes because they may contain plastic burr particulate from the protective cap.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class I, which typically indicates a low probability of adverse health consequences, aligning with a Moderate severity score for a potential particulate issue without reported injuries.
Plain-English summary
ICU Medical, Inc. is recalling 3,500 units of SetSource ChemoClave Vented Vial Spike, 20mm, REF Z7148. The affected lots are 3872008 and 3899761. These devices are needle-free Closed System Transfer Devices used in IV administration sets to minimize exposure to hazardous drugs.
The recall is due to a potential for plastic burr particulate originating from the protective cap used in the assembly of the device. The source text notes that this issue may also affect certain lots of ChemoLock Vial Spikes.
The affected products were distributed worldwide, including the US nationwide, Canada, France, and Singapore. Healthcare facilities and users should check their inventory for the specific lot numbers listed and stop using the affected devices.
The recalled product
- Product
- SetSource ChemoClave Vented Vial Spike, 20mm, REF Z7148. 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 contaminants
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 3,500
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 (2)
- Lot Numbers: 3872008
- 3899761
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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