Recall: ChemoLock and ChemoClave Vial Spikes
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 83 food recalls.
Company Contact Information:
Name: ICU Medical
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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
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.