FDA Initiates Recall On Chemotherapy Equipment, ChemoLock Vial Spike
Contending with cancer is one of the most difficult and intense experiences that a person can go through. With so much on the line, every part of the process, from doctors to medicine, must be of the best quality available. Unfortunately, the FDA released a Class I Recall that seems to indicate that at least one part of some patients cancer treatment is not working as expected: their medication dispersal unit. Specifically, the recall issued was for ICE Medical’s Chemolock Vial Spike.
About The ChemoLock Vial Spike
The ChemoLock Vial Spike is a medical device that does not utilize needles to infuse patients with their chemotherapy drugs. The main selling point of ICU Medical’s ChemoLock Vial Spike was that it would preserve the health of both clinicians and patients. For patients, the ChemoLock Vial Spike kept dust and other particles out of the infusion to prevent contamination. For clinicians, the ChemoLock Vial Spike prevented leakage of chemotherapy drugs out of the mechanism and into the clinician’s body. Clinicians exposed to chemotherapy drugs, according to ICU Medical’s site, can develop hair loss, skin rashes, infertility, miscarriages, congenital disabilities, and even be put at risk for certain types of cancer.
Risks Of Using The ChemoLock Vial Spike
Unfortunately, ICU Medical is recalling the ChemoLock Vial Spike because it was discovered that particles of plastic were breaking off of the protective caps and were potentially entering the bloodstreams of patients. Once inside, the plastics could cause embolisms which could result in severe damage to the internal organs and even death in some cases.
In early January of this year, ICU Medical sent hospitals and distributors an “Urgent Medical Device Recall” according to the U.S. Food and Drug Administration (FDA) report. Within this letter was a series of instructions that described the correct procedure for handling the recall including:
- Discontinuing the use of the ChemoLock Vial Spike
- Quarantining all recalled inventory
- Informing users of the risk of complications
- Returning affected product
- Completing a Medical Device Recall Response form
Although ICU Medical began the recall on January 3rd, 2019; the FDA only formally acknowledged the recall on February 22nd, 2019. In that time, ICU Medical reports no complications or fatalities.
Compensation For Defective Medical Devices
Although ICU Medical is attempting to correct their mistakes, for some that correction comes too little and too late. If you or a loved one have suffered complications, severe injury, or wrongful death as a result of using ICU Medical’s ChemoLock Vial Spike, compensation may be available to you. Parker Waichman LLP has attorneys with extensive experience with defective medical devices and they can help you and your family receive the compensation deserved from this gross negligence. Contact Parker Waichman today for a free consultation.