ICU Medical Recalls ChemoClave Vial Spikes Due to Plastic Particulate
ICU Medical is recalling specific lots of ChemoClave Vented Vial Spikes because they may contain plastic burr particulate from the protective cap.
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 risk-of-harm product (medical device with potential particulate contamination) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
ICU Medical, Inc. is recalling 60,500 units of ChemoClave Vented Vial Spikes, 20 mm, REF CH-80S. These needle-free Closed System Transfer Devices are used in IV administration sets to minimize exposure to hazardous drugs during preparation and administration.
The recall is due to a potential for plastic burr particulate originating from the protective cap used in the assembly of the device. The affected lots are 3826647, 3826648, 3826844, 3827598, 3839689, 3839690, 3854000, 3854001, 3866761, 3873006, 3936065, and 3952512.
The affected devices were distributed worldwide, including the United States, Canada, France, and Singapore. Healthcare facilities and distributors should stop using the affected lots and contact ICU Medical for instructions on return or disposal.
The recalled product
- Product
- icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-80S. 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 contaminan
- Manufacturer
- ICU Medical, Inc.
- Affected units
- 60,500
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 (12)
- Lot Numbers: 3826647
- 3826648
- 3826844
- 3827598
- 3839689
- 3839690
- 3854000
- 3854001
- 3866761
- 3873006
- 3936065
- 3952512
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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