Product Description/Item: ChemoLock Vial Spike, 20mm/011-CL-80S; ChemoLock Bag Spike/CL-10; ChemoLock w/Mini Bag Spike/CL-17; 8 IN (20cm) APPX 1.0ml, EXT SET, MicroClave Clear, ChemoLock PORT, YCONN/CL3950; 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros, Purple Cap, Hanger/CL3951; 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock Port, Clamp, Graduated Adapter/CL3967; 6 IN(15cm)APPX 0.82ml,EXT SET,MicroClave Clear,ChemoLock PORT,YCONN, ROTATING LUER/CL4118; ChemoLock Kit w/ 5" (13 cm) Bag Spike Adapter w/ChemoLock w/Red Cap, Vented Cap, ChemoLock Port Bag Spike/CL4158; ChemosafeLock Bag Spike/KL-BS001U3; ChemosafeLock Vial Adapter/KL-VA201U3; ChemosafeLock Vial Adapter/KL-VA202U3; ChemosafeLock Vial Adapter/KL-VA321U3; ChemosafeLock Vial Adapter/KL-VA322U3; ChemoLock Vented Vial Spike/011-CL-51; Transfer Set, PUR Yellow w/ChemoLock Port, Spiros/011-CL4155; Puerto ChemoLock/034-CL2100; ChemoLock, Punzon Univ. Vial c/ Filtro, fijacion/034-CL-70; ChemoLock, Punzon Vial Tritan c/ Filtro, 13mm/034-CL-72
- Company
- Icu Medical, Inc.
- Recall Initiated
- June 27, 2022
- Recall Number
- Z-1682-2022
- Quantity
- 358,975
- Firm Location
- Amanecer San Clemente, CA
Reason for Recall
Ports 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.
Distribution
Worldwide 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, United Arab Emirates, Spain, Slovenia, Japan, Canada.
Lot / Code Info
OUS Distributed Only Item/Lots: 011-CL-80S/5843950; CL-10/5850516; CL-17/5816314, 5829878, 5842209, 5850503; CL3950/5845117, 5885020; CL3951/5842199, 5872831; CL3967/5829901, 5842210; CL4118/5825274, 5872840; KL-BS001U3/5851020, 5851021, 5851022, 5910255, 5910258; KL-VA201U3/5819364; KL-VA202U3/5819370, 5910262; KL-VA321U3/5915973; KL-VA322U3/5920744; 011-CL-51/5850505; 011-CL4155/5816324; 034-CL2100/5842230; 034-CL-70/5816321; 034-CL-72/5816344
Root Cause
Component design/selection
Action Taken
On 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 achieved or is difficult to achieve, discard product and utilize a new device. 3) Complete and return the response form. 4) The recalling firm's customer service can be contacted for product availability information. 5) Return affected product using the return label provided. Contact Sedgwick if you have not received a return label or require additional labels. 6) If you have distributed the product further, immediately notify your accounts and ask them to contact Sedgwick. For further inquiries, please contact: Global Complaint Management 1-844-654-7780 or ProductComplaintsPP@icumed.com; Customer Service 1-866-829-9025, option 8 or customerservice@icumed.com; Sedgwick 1-888-943-5190 (M-F, 8am-5pm ET)