- ICU Medical issued Feb. 25 an urgent medical device recall of ChemoLock and ChemoClave Vial Spikes because plastic particles could detach from the protective cap and enter a patient’s bloodstream.
The Food and Drug Administration (FDA) classified the recall as Class I, the most serious type of recall because the plastic pieces could damage organs or lead to a stroke resulting in injury or death.
Used in hospitals and clinics, the ChemoLock and ChemoClave Vial Spikes are designed to keep environmental contaminants out of a drug delivery system and to prevent drug and vapor concentrations from leaking out of the system.
The affected products were distributed in the U.S. market between August 2018 and February 2019. A total of 78 lots are involved in the recall.
ICU Medical did not disclose the total number of products impacted by the recall, but a previous recall that impacted only one lot involved more than 2,000 units of the 20mm ChemoLock Vial Spikes. ICU Medical spokesman Tom McCall told HITInfrastructure.com: “These are high volume consumables, and we believe most have already been used and are out of the system.”
ICU Medical is instructing customers to:
- Discontinue the use and distribution of the affected product immediately. Check your inventory and quarantine all affected product at your facility.
- Inform potential users of the product in your organization of this notification and complete and return a response form.
- Return affected product. Upon receipt of the completed response form and return of the affected product, ICU Medical will credit you for any product returned.
- If you have distributed the product further, immediately notify your accounts that received the affected products and ask them to contact Stericycle at 1-888-871-7114 (M-F, 8am-5pm ET) to obtain a response form.
ICU Medical said it had not received any reports of adverse events related to this problem. “Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program,” the company related.