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Recall Observatory FDA recall evidence

Device 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

Z-1682-2022

June 27, 2022

Class II

Product summary

Firm
ICU Medical, Inc.
Event
Event 90606
Status
Ongoing
Classification
Class II
Quantity
358,975
Official record key
device-enforcement:Z-1682-2022

Official wording

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.

Code information: 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

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.