ICU Medical Recalls ChemoLock Vial Spikes Due to Plastic Particulate
ICU Medical is recalling specific lots of ChemoLock Vial Spikes because they may contain plastic burr particulate from the protective cap.
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 23,800 units of ChemoLock Closed Vial Spike w/Skirt devices. The affected products include reference numbers CL-80S-4 and CL-80S-5. These devices are used in IV administration sets to prevent the transfer of environmental contaminants and the escape of drug or vapor concentrations.
The recall was initiated because there is a potential for certain lots of the devices to have plastic burr particulate originating from the protective cap used in the assembly of the device. The affected lot numbers for CL-80S-4 are 3820520, 3820521, and 3844785. The affected lot numbers for CL-80S-5 are 3820516, 3820523, 3839238, 3839239, 3844781, 3844782, 3853998, 3853999, 3866769, 3866770, 3872090, 3910645, 3932908, 3932910, 3946770, and 3951236.
The devices were distributed worldwide, including nationwide in the United States and in Canada, France, and Singapore. Healthcare facilities and consumers should check their inventory for these specific reference numbers and lot numbers and stop using the affected devices.
The recalled product
- Product
- icumedical ChemoLock Closed Vial Spike w/Skirt, (a) REF CL-80S-4 (4 units) (b) REF CL-80S-5 (5 units). Used in IV administration sets. The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and…
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 23,800
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 (20)
- (a) REF CL-80S-4
- Lot Numbers: 3820520
- 3820521
- 3844785 (b) REF CL-80S-5
- Lot Numbers: 3820516
- 3820523
- 3839238
- 3839239
- 3844781
- 3844782
- 3853998
- 3853999
- 3866769
- 3866770
- 3872090
- 3910645
- 3932908
- 3932910
- 3946770
- 3951236
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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