ICU Medical Issues a Voluntary Nationwide Recall of Certain Lots of ChemoLock(TM) and ChemoClave® Vial Spikes Due to the Potential for Burr Particulate
SAN CLEMENTE, Calif., Feb. 25, 2019 /PRNewswire/ -- ICU Medical, Inc. today announced a voluntary recall of certain lots of ChemoLock(TM) 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:
Item Number
Description
Lot Number
---
CH3943 Oncology Kit w/12" Ext Set w/
Spiros(TM) w/Red Cap, Clamp,
Graduated Adapter; ChemoClave(TM)
Vented Vial Spike, 20mm;
ChemoClave(TM) Vented Vial Spike,
13mm; Spiros(TM) w/Red Cap
3846114, 3855564, 3902719, 3961122
---
CH3944 Oncology Kit w/12" Ext Set w/
Spiros(TM) w/Red Cap, Clamp,
Graduated Adapter; ChemoClave(TM)
Vented Vial Spike, 20mm;
ChemoClave(TM) Vented Vial Spike,
13mm
3846116, 3855565
---
CH-70S ChemoClave(R) Vented Vial Spike, 20mm
3866759, 3872252, 3910046, 3910627
---
CH-80S ChemoClave(R) Vial Spike, 20mm
3826647, 3826648, 3826844, 3827598
3839689, 3839690, 3854000, 3854001
3866761, 3873006, 3936065, 3952512
---
CL-80S ChemoLock(TM) Vial Spike, 20mm
3757712, 3824204, 3824209, 3826652
3828646, 3829557, 3836196, 3836811
3853995, 3853997, 3866764, 3866766
3872065, 3872072, 3872085, 3872093
3872433, 3872444, 3910642, 3920773
3932270, 3945868, 3946776
---
CL-80S-10 ChemoLock(TM) Vial Spike, 20mm, 10
units
3820519, 3820522, 3839240, 3839241
3844783, 3844784, 3854004, 3854005
3910656, 3932907, 3946771, 3946772
---
CL-80S-4 ChemoLock(TM) Closed Vial Spike w/
Skirt, 4 Units
3820520, 3820521, 3844785
---
CL-80S-5 ChemoLock(TM) Closed Vial Spike w/
Skirt, 5 Units
3820516, 3820523, 3839238, 3839239
3844781, 3844782, 3853998, 3853999
3866769, 3866770, 3872090, 3910645
3932908, 3932910, 3946770, 3951236
---
Z7148 ChemoClave(R) 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 experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
-- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
-- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or
call 1-800-332-1088 to request a reporting form, then complete and
return to the address on the pre-addressed form, or submit by fax to
1-800-FDA-0178
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.
Media Contact:
Tom McCall
ICU Medical, Inc.
949-366-4368
tom.mccall@icumed.com
SOURCE ICU Medical, Inc.
