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  4. ICU Medical Issues a Voluntary Nationwide Recall of Certain Lots of ChemoLock™ and ChemoClave® Vial Spikes Due to the Potential for Burr Particulate
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COMPANY ANNOUNCEMENT

ICU Medical Issues a Voluntary Nationwide Recall of Certain Lots of ChemoLock™ and ChemoClave® Vial Spikes Due to the Potential for Burr Particulate

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Oncology
Reason for Announcement:
Recall Reason Description
Due to the Potential for Burr Particulate
Company Name:
ICU Medical, Inc.
Brand Name:
Brand Name(s)
ChemoLock and ChemoClave
Product Description:
Product Description
Vial Spikes

Company Announcement

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:


Item Number
Description Lot Number
CH3943 Oncology Kit w/12" Ext Set w/Spiros™ w/Red Cap, Clamp, Graduated Adapter; ChemoClave™ Vented Vial Spike, 20mm; ChemoClave™ Vented Vial Spike, 13mm; Spiros™ w/Red Cap 3846114, 3855564, 3902719, 3961122
CH3944 Oncology Kit w/12" Ext Set w/Spiros™ w/Red Cap, Clamp, Graduated Adapter; ChemoClave™ Vented Vial Spike, 20mm; ChemoClave™ Vented Vial Spike, 13mm 3846116, 3855565
CH-70S ChemoClave® Vented Vial Spike, 20mm 3866759, 3872252, 3910046, 3910627
CH-80S ChemoClave® Vial Spike, 20mm 3826647, 3826648, 3826844, 3827598
3839689, 3839690, 3854000, 3854001
3866761, 3873006, 3936065, 3952512
CL-80S ChemoLock™ Vial Spike, 20mm 3757712,3824204, 3824209, 3826652
3828646, 3829557, 3836196, 3836811
3853995, 3853997, 3866764, 3866766
3872065, 3872072, 3872085, 3872093
3872433, 3872444, 3910642, 3920773
3932270, 3945868, 3946776
CL-80S-10 ChemoLock™ Vial Spike, 20mm, 10 units 3820519, 3820522, 3839240, 3839241
3844783, 3844784, 3854004, 3854005
3910656, 3932907, 3946771, 3946772
CL-80S-4 ChemoLock™ Closed Vial Spike w/Skirt, 4 Units 3820520, 3820521, 3844785
CL-80S-5 ChemoLock™ Closed Vial Spike w/Skirt, 5 Units 3820516, 3820523, 3839238, 3839239
3844781, 3844782, 3853998, 3853999
3866769, 3866770, 3872090, 3910645
3932908, 3932910, 3946770, 3951236
Z7148 ChemoClave® Vented Vial Spike, 20mm 3872008, 3899761

The FDA is classifying this as a Class 1 recall, as burr particulate has the potential to detach and, in rare circumstances, enter the fluid path causing an embolism that may damage organs or lead to a stroke, resulting in serious injury or death. To date, ICU Medical has not received any reports of adverse events related to this matter and is issuing this notification out of an abundance of caution.

ICU Medical is asking customers to discontinue the use and distribution of the affected product immediately. Check your inventory and quarantine all affected product at your facility and return the affected product to Stericycle for credit. For instructions on returning product or additional assistance, call Stericycle at 1-888-871-7114 Monday through Friday, between the hours of 8 a.m. to 5 p.m. Eastern Time.

Customers with questions regarding this recall can call ICU Medical at 1-877-946-7747, Monday through Friday, between the hours of 8 a.m. and 5 p.m. Central Time.

Adverse reactions or quality problems associated with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Additional information regarding this recall, along with notifications to the customer can be found on ICU Medical’s Website here


Company Contact Information

Consumers:
ICU Medical
1-877-946-7747
Media:
Tom McCall
949-366-4368
tmccall@icumed.com