Agency classClass IOur severity:Severe FDA (Devices)·Z-1098-2019·Announced 2019-04-24

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.

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 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.
Category: Medical Device — IV Administration
Hazard: foreign-object
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.

See all 7 products in this recall →

Same manufacturer · ICU Medical, Inc.

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Same hazard · foreign object