FDA Medical Device Recalls (openFDA)
ICU Medical, Inc.: 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
- Recall number
- Z-1682-2022
- Recalling firm
- ICU Medical, Inc.
- Product
- 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
- Status
- Open, Classified
- Initiated
- 2022-06-27
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Component design/selection
- Action
- 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)
- Quantity
- 358,975
- 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, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- ONB
- Firm FEI
- 2025816
- Firm city
- San Clemente
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28