ICU Medical Recalls ChemoLock Vial Spikes, 20mm Lot #3757712
February 28th, 2019
A Class 1 Recall has been issued for a lot Chemolock Vial Spikes manufactured by ICU Medical on August 13, 2018 and distributed from August-September. The lot number of this recall is 3757712. Apparently, this particular lot contains a manufacturing defect which could potentially lead to serious injury or death.
The Defect in Lot 3757712
Chemolock Vial Spikes are basically a plastic spike with a cap that inserts into a closed drug vial in order to allow access to the injectionable without contaminates getting in or medication leaking out. According to the recall, there is a risk of pieces of the plastic cap breaking off and “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.”
Consumers Urged to Discontinue Use of the Recalled Chemolock Vial Spikes
In a letter sent to its medical customers, ICU Medical urged anyone who received Chemolock Vial Spikes with Lot number 3757712 to do take the following steps:
- 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.
A Class 1 recall is the most serious type of recall in that it involved a recall of something that has the potential to case serious injury or death. For questions regarding the Chemolock Vial Spike recall, you can call the manufacturer at: 1-949-366-4208.
If you or a loved one has been injured as a result of this product, please feel free to contact Simmons and Fletcher’s product liability attorneys for a legal consultation.
Paul Cannon has practiced personal injury trial law since 1995. He is Board Certified in Personal Injury Trial Law (2005). He has earned recognition as a Super Lawyer by Thompson Reuters in 2017 & 2018, and as a Top 100 Trial Lawyer by the National Trial Lawyers Association in 2017. He is a Shareholder, trial lawyer and online marketing manager at Simmons and Fletcher, P.C. His legal writings have been published by the Texas Bar Journal, Business.com, Lawyer.com HG Legal Resources, Lawfirms.com, and others. He has been asked to give education talks and media interviews on dog bite law.