ICU Medical Recalls ChemoLock Devices Due to Plastic Particulate
ICU Medical is recalling specific lots of ChemoLock devices 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 specific lots of ChemoLock, 20mm, Closed System Drug Transfer Devices. The recall affects 160,775 units of REF CL-80S and REF CL-80S-10 (10 units). 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 is being conducted because there is a potential for certain lots to have plastic burr particulate originating from the protective cap used in the assembly of the device. The ChemoLock is a needle-free device designed to aid in preventing needlestick injuries and exposure to cytotoxic medications for healthcare personnel.
The affected devices were distributed worldwide, including nationwide in the US and in Canada, France, and Singapore. Specific lot numbers for REF CL-80S include 3824204, 3824209, 3826652, 3828646, 3829557, 3836196, 3836811, 3853995, 3853997, 3866764, 3866766, 3872065, 3872072, 3872085, 3872093, 3872433, 3872444, 3910642, 3920773, 3932270, 3945868, and 3946776. Specific lot numbers for REF CL-80S-10 include 3820519, 3820522, 3839240, 3839241, 3844783, 3844784, 3854004, 3854005, 3910656, 3932907, 3946771, and 3946772. Healthcare facilities should check their inventory for these specific lot numbers and stop using the affected devices.
The recalled product
- Product
- icumedical ChemoLock, 20mm, (a) REF CL-80S (b) REF CL-80S-10 (10 units). Used in IV administration sets. The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system…
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 160,775
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
- Lot numbers: 3824204
- 3824209
- 3826652
- 3828646
- 3829557
- 3836196
- 3836811
- 3853995
- 3853997
- 3866764
- 3866766
- 3872065
- 3872072
- 3872085
- 3872093
- 3872433
- 3872444
- 3910642
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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