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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 10 of 18 Results
510(K) Number: K131549
 
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Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10; ChemoLock BAG SPIKE w/ ADDITIVE P... 2 09/07/2022 ICU Medical, Inc.
REF CL3960 Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/w/ChemoLock Port, Clamp, Ant... 2 05/13/2021 ICU Medical, Inc.
REF CL3946 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock , S... 2 05/13/2021 ICU Medical, Inc.
REF CL3538 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock , S... 2 05/13/2021 ICU Medical, Inc.
REF CL3011 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated w/ChemoLock Drip Chamber, Spiros ... 2 05/13/2021 ICU Medical, Inc.
REF CL4151 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp... 2 05/13/2021 ICU Medical, Inc.
REF CL3028T 30" (76 cm) Appx 6.1 ml, 20 Drop Admin Set w/Integrated w/ChemoLock Drip Chamber, 0.2 Mi... 2 05/13/2021 ICU Medical, Inc.
30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber, Spiros w/Red Cap, Ha... 2 12/23/2020 ICU Medical, Inc.
icumedical ChemoLock, 20mm, (a) REF CL-80S (b) REF CL-80S-10 (10 units). Used in IV administra... 1 04/15/2019 ICU Medical, Inc.
icumedical ChemoLock Vial Spike, 20mm, REF CL-80S The ChemoLock Closed System Drug Transfer Devi... 1 02/22/2019 ICU Medical, Inc.
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