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Home > Recalled Products > Drugs > Particulate Matter > ChemoLock and ChemoClave Vial Spikes

Recall: ChemoLock and ChemoClave Vial Spikes

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On 2019-02-25, the FDA announced that ICU Medical is conducting a recall on Vial Spikes due to a possible particulate matter. The recalled products were sold under the brand name(s) ChemoLock and ChemoClave during an unspecified time period throughout the regions shown in the map below.

In recent months, there have been 2 drugs recalls due to potential particulate matter, including vecuronium bromide for injection, prednisolone and gatifloxacin ophthalmic solution and more. Additionally, there have been 18 drug and medical device recalls due to other health hazards as well as 77 food recalls.

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ICU Medical Inc., Company Logo
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Company Contact Information:

Name: ICU Medical
Phone: 1-877-946-7747

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Detailed Recall Information



Regions Where Sold: Because the region was not specified, it is assumed that this product was available nationwide.

Product Description: Vial Spikes

Brand Name(s): ChemoLock and ChemoClave

Reason for Recall: Particulate Matter

Official Recall Date: 2019-02-25


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Additional information provided by the FDA.gov:

ICU Medical, Inc. today announced a voluntary recall of certain lots of ChemoLock and ChemoClave Vial Spikes due to the potential for burr particulate originating from the protective cap used in the assembly of the device. The affected product lot was distributed nationwide to ICU Medical customers between August 2018 and February 2019. The affected lots are listed below: Read More.


More information may be available at FDA.gov
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Sources may include Food & Drug Administration (FDA), United States Department of Agriculture (USDA), Health Canada and companies involved with this or a related recall.

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