ICU Medical, Inc.: 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.

Agency Publication Date: September 7, 2022

Affected Products

Product: 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, Hanger/CL3011; 9 IN(23cm)APPX 2.7ml,EXT SET,ChemoLock PORT,2 CLAMPS,2 GRADUATED CONN/

Item/UDI-DI/Lots: CL-10-10/10887709071022/5872839, 5891255; CL-12/10887709056975/5819981, 5856055, 5873186; CL-13/10887709056982/5850811; CL2100/5797867, 5816334, 5829882,5850510; CL2100-5/10887709122960/5754377; CL2100T/10887709099293/5816341, 5842229, 5850517; CL2150/10887709094670/5829900, 5850507; CL3011/10887709057019/5829885, 5842227; CL3364/10887709073408/5841261, 5850805; CL-34/10887709069777/5754437, 5829875; CL3511/10887709057026/5842231, 5861991, 5894477; CL3511T/10887709120010/5829831, 5891263; CL3528/10887709057040/5850500, 5872833, 5883793, 5894481, 5909807; CL3535T/10887709099613/5685350; CL3538/10887709071909/5935851; CL3900/10887709071411/5772697; CL3927/10887709075440/5842211; CL3946/10887709080291/5829895, 5861983; CL3947/10887709080307/5782844; CL3952/10887709081571/5782863,5816379; CL3955/10887709082509/5841209, 5850839; CL3960/10887709083278/5816328, 5842216; CL3963/10887709083827/5842214,5851775; CL4114/10887709091136/5754773, 5782864, 5816356; CL4130/10887709095530/5850515; CL4131/10887709095776/5895940; CL4136/10887709096131/5816325, 5850661; CL4143/10887709097213/5782848, 5873243, 5891266; CL4146-5/10887709097466/5872843, 5883800, 5909812; CL4153/10887709098722/5816348; CL4159/10887709121369/5881696; CL4179/10887709123578/5872687; CL-62/10887709057088/5816320,5825248; CL-70/10887709057095/5842228; CL-70-10/10887709070988/5816343, 5851774; CL-70-10T/10887709099477/5816353; CL-70S/10887709067155/5842225,5850512; CL-70S-5/10887709070995/5816326, 5851776; CL-70T/10887709099507/5816350; CL-72/10887709062440/5829832, 5849740, 5816312; CL-72T/10887709099552/5841181, 5849748; CL-76/10887709122878/5816323, 5842218; CL-80/10887709057125/5804034, 5842200, 5850499; CL-80S/10887709069593/5808063, 5816306, 5829020, 5829023, 5841982, 5845354, 5862839; CL-80S-10/10840619080577/5804045, 5816315; CL-80S-10T/10887709120539/5804051, 5816310, 5829022, 5841994, 5849630, 5850497, 5871336; CL-80S-5/10887709077116/5667054, 5829021, 5829024, 5841980, 5849474, 5849631, 5849632, 5849713, 5849714, 5849715, 5849716, 5849474; CL-80SL/10887709069630/5816317; CL-82/10887709085692/5804065; CLH-12/10887709080413/5842212

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/CL41

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

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90606

Status: Active

Manufacturer: ICU Medical, Inc.

Manufactured In: United States

Units Affected: 2 products (454,635; 358,975)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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Affected Products