ICU Medical, Inc. today announced a voluntary recall of certain lots of ChemoLock™ and ChemoClave® Vial Spikes due to the potential for burr particulate originating from the protective cap used in the assembly of the device. The affected product lot was distributed nationwide to ICU Medical customers between August 2018 and February 2019. The affected lots are listed below:
|Cb943||Oncology Kit w/12" Ext Set w/Spiros™ w/Red Cap, Clamp, Graduated Adapter; ChemoClave™ Vented Vial Spike, 20mm; ChemoClave™ Vented Vial Spike, 13mm; Spiros™ w/Red Cap||3846114, 3855564, 3902719, 3961122|
|Cb944||Oncology Kit w/12" Ext Set w/Spiros™ w/Red Cap, Clamp, Graduated Adapter; ChemoClave™ Vented Vial Spike, 20mm; ChemoClave™ Vented Vial Spike, 13mm||3846116, 3855565|
|CH-70S||ChemoClave® Vented Vial Spike, 20mm||3866759, 3872252, 3910046, 3910627|
|CH-80S||ChemoClave® Vial Spike, 20mm||3826647, 3826648, 3826844, 38275983839689, 3839690, 3854000, 3854001|
3866761, 3873006, 3936065, 3952512
|CL-80S||ChemoLock™ Vial Spike, 20mm||3757712,3824204, 3824209, 38266523828646, 3829557, 3836196, 38368113853995, 3853997, 3866764, 38667663872065, 3872072, 3872085, 38720933872433, 3872444, 3910642, 3920773|
3932270, 3945868, 3946776
|CL-80S-10||ChemoLock™ Vial Spike, 20mm, 10 units||3820519, 3820522, 3839240, 38392413844783, 3844784, 3854004, 3854005|
3910656, 3932907, 3946771, 3946772
|CL-80S-4||ChemoLock™ Closed Vial Spike w/Skirt, 4 Units||3820520, 3820521, 3844785|
|CL-80S-5||ChemoLock™ Closed Vial Spike w/Skirt, 5 Units||3820516, 3820523, 3839238, 38392393844781, 3844782, 3853998, 38539993866769, 3866770, 3872090, 3910645|
3932908, 3932910, 3946770, 3951236
|Z7148||ChemoClave® Vented Vial Spike, 20mm||3872008, 3899761|
The FDA is classifying this as a Class 1 recall, as burr particulate has the potential to detach and, in rare circumstances, enter the fluid path causing an embolism that may damage organs or lead to a stroke, resulting in serious injury or death. To date, ICU Medical has not received any reports of adverse events related to this matter and is issuing this notification out of an abundance of caution.
ICU Medical is asking customers to discontinue the use and distribution of the affected product immediately. Check your inventory and quarantine all affected product at your facility and return the affected product to Stericycle for credit. For instructions on returning product or additional assistance, call Stericycle at 1-888-871-7114 Monday through Friday, between the hours of 8 a.m. to 5 p.m. Eastern Time.
Customers with questions regarding this recall can call ICU Medical at 1-877-946-7747, Monday through Friday, between the hours of 8 a.m. and 5 p.m. Central Time.
Adverse reactions or quality problems associated with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Additional information regarding this recall, along with notifications to the customer can be found on ICU Medical’s Website here