ClearanceBrief
Recall Z-1681-2022 ยท ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

ICU Medical, Inc.

Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10; ChemoLock BAG SPIKE w/ ADDITIVE PORT, DRY SPIKE/CL-12; APPX 1.5ml,ChemoLock BAG SPIKE WITH ADDITIVE PORT/CL-13; ChemoLock Port/CL2100; ChemoLock Port, 5 Units/CL2100-5; ChemoLock Port/CL2100T; Clave Bag Spike w ChemoLock Port/CL2150; 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w Integrated ChemoLock Drip Chamber, Spiros w/Red Cap

DateJun 27, 2022
StatusOpen, Classified
ReasonPorts have a potential for unintended disconnection, inability to connect to or fully engage with injectors, due to a variation in the spring inside the Port, which may cause delay of therapy and exposure to caustic substances. Ports available as standalone connectors, or utilized as access points on vial adaptors, bag spikes, and administration sets.
Root causeComponent design/selection
ActionOn 06/27/2022 recall notices were mailed to customers who were asked to do the following: 1) Discontinue the use and distribution of the affected product immediately. Check your inventory and quarantine all affected product at your facility. 2) In instances where the benefits of using the ChemoLock are greater than the potential risks for non-connection or disconnection, and you choose to utilize ChemoLock affected lot numbers, ensure full engagement between the ChemoLock Port and ChemoLock Injector. If full engagement is achieved, the device will work as intended. If full engagement cannot be
Quantity454,635
DistributionWorldwide distribution - US Nationwide distribution including in the states of LA, FL, TX, NY, NE, WI, PA, IA, ND, CA, OH, WA, GA, AL, CO, AZ, NC, TN, MI, VA, MA, DE, OR, KY, CT, OK, NJ, MN, IL, VT, AR, RI, ID, IN, UT, NV, MT, MD, KS, SC, NM, ME, MO, SD and the countries of : Saudi Arabia, Australia
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K131549CHEMOLOCK, CHEMOLOCK PORT
Icu Medical, Inc., Jul 26, 2013