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 used during assembly.
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 FDA classified this recall as Class I, which mandates a minimum severity score of 4 according to the rubric, as it indicates a reasonable probability of serious adverse health consequences.
Plain-English summary
ICU Medical, Inc. is recalling 18,150 units of the ChemoCLAVE Cytotoxic Medication Preparation and Delivery System, specifically the ChemoClave Viented Vial Spikes (20mm and 13mm) and associated Oncology Kits. The recall affects lot numbers 3846114, 3855564, 3902719, and 3961122. These devices are used in IV administration sets for the preparation and patient administration of cytotoxic medications.
The recall was initiated because 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. The FDA has classified this recall as Class I, indicating a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death.
The affected devices were distributed worldwide, including nationwide in the United States and in Canada, France, and Singapore. Healthcare facilities and patients who have used or are using these specific lots should contact ICU Medical or their healthcare provider for instructions on how to proceed.
The recalled product
- Product
- icumedical Oncology Kit w/12" Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter; ChemoClave Vented Vial Spike, 20mm; ChemoClave Vented Vial Spike, 13mm; Spiros wRed Cap, REF 3943. Used in IV administration sets. The ChemoCLAVE Cytotoxic Medication Preparation and Delivery…
- Manufacturer
- ICU Medical, Inc.
- Affected units
- 18,150
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: 3846114
- 3855564
- 3902719
- 3961122
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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