U.S. Food and Drug Administration02.25.19
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death
Recalled Product(s)
The 20mm ChemoLock Vial Spike is intended to keep environmental contaminants—like bacteria and dust—out of a drug delivery system and to prevent drug or vapor concentrations from leaking out of the system. The device consists of a spike and clasp which penetrates the drug container as well as a cap which protects the spike prior to use.
ChemoLock is used by health care professionals in compounding pharmacies and health care facilities.
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.
Healthcare facilities (for example, hospitals and clinics) and healthcare professionals using ChemoLock Vial Spike and patients receiving medication from a ChemoLock Vial Spike may be affected.
On January 3, 2019, ICU Medical sent customers an “Urgent Medical Device Recall” letter. The letter instructed customers to:
Customers who have questions or need additional information regarding this recall may contact ICU Medical Customer Care at 1-949-366-4208.
The recall was initiated January 14, 2019
Recalled Product(s)
- 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
The 20mm ChemoLock Vial Spike is intended to keep environmental contaminants—like bacteria and dust—out of a drug delivery system and to prevent drug or vapor concentrations from leaking out of the system. The device consists of a spike and clasp which penetrates the drug container as well as a cap which protects the spike prior to use.
ChemoLock is used by health care professionals in compounding pharmacies and health care facilities.
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.
Healthcare facilities (for example, hospitals and clinics) and healthcare professionals using ChemoLock Vial Spike and patients receiving medication from a ChemoLock Vial Spike may be affected.
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.
Customers who have questions or need additional information regarding this recall may contact ICU Medical Customer Care at 1-949-366-4208.
The recall was initiated January 14, 2019
