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;
Check against the official notice below — it lists the full affected range.
ICU Medical, Inc. is recalling approximately 454,635 ChemoLock Bag Spike units and related products distributed worldwide, including across numerous U.S. states and several countries including Canada, Australia, Japan, Spain, Saudi Arabia, and the United Arab Emirates. The recalled products contain ports with a variation in the internal spring that can cause unintended disconnection or inability to fully engage with injectors, potentially delaying therapy and exposing patients to caustic substances.
The recall affects multiple product models and lot codes identified in the recall notice. The source document does not specify a remedy or action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Quantity: 454,635 Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.