Class I Recall of ICU Medical ChemoLock Vial Spike (20mm)
ICU Medical is recalling one lot of ChemoLock Vial Spikes, 20mm due to the potential for plastic particles to break off the protective cap. In uncommon circumstances a plastic particle could enter the drug delivery system and be infused into a patient's intravenous line, which could potentially enter the patient and lead to an embolism.
To date, ICU Medical has not received any reports of adverse events related to this issue, although the risk of introducing foreign particulates into the patient's body, can cause serious injury or death.
Recalled Product Details:
- ChemoLock Vial Spike, 20mm
- Lot Number: 3757712
- Manufacturing Dates: August 13, 2018 to August 13, 2018
- Distribution Dates: August 2018 to September 2018.
- Devices Recalled in the U.S.: 2050 Units of CL-80S ChemoLock Vial Spike
On January 3, 2019, ICU Medical sent customers an “Urgent Medical Device Recall” letter. The letter instructed 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.
- Complete and return the Medical Device Recall Response form enclosed with the firm's recall letter.
- Fax the completed form to 1-855-497-9856 or
- E-mail the form to ICUMEDICAL6834@stericycle.com, even if you do not have the affected product.
- Return affected product using the return label provided with the firm's recall letter. Contact Stericycle at 1-888-871-7114 (M-F, 8am-5pm ET) if you have not received a return label or require additional labels for returning the affected product.
- If you have distributed the product further, immediately notify your accounts that received the product identified in this recall and ask them to contact Stericycle at 1-888-871-7114 (M-F, 8am-5pm ET) to obtain a response form.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
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