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/CL3364; Syringe Transfer Set w Clave, ChemoLock Port/CL-34; 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w Integrated ChemoLock Port Drip Chamber, ChemoLock w Red Cap, Bag Hanger/CL3511; 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w Integrated ChemoLock Port Drip Chamber, ChemoLock w Red Cap, Bag Hanger/CL3511T; 30" (76cm) Appx 6.3 ml, 20 Drop Admin Set w Integrated ChemoLock Port Drip Chamber, 0.2 Micron Filter, ChemoLock w Red Cap, Hanger/CL3528; 7" (18 cm) Appx .93 ml, Ext Set w/ChemoLock, Y-Connector, Rotating Luer/CL3535T; Oncology Kit w/5" (13 cm) Add-On Set w ChemoLock Additive Port, Vented Cap, ChemoLock, Spinning Spiros w Red Cap/CL3538; Graduated Connector w ChemoLock Port/CL3900; ONCOLOGY KIT, EXT,ChemoLock PORT, GRAD CONN,TRANSFER,ChemoLock,VIAL SPIKE,ChemoLock PORT/CL3927; Oncology Kit w 5" (13 cm) Add-On Set w ChemoLock w Red Cap, Vented Cap, ChemoLock Port w Bag Spike, Spiros w Red Cap/CL3946; Oncology Kit w 17" (43 cm) Bifuse Ext Set w/ChemoLock w Red Cap, ChemoLock Port, ChemoLock Vented Vial Spike, 13mm ChemoLock/CL3947; Oncology Kit w ChemoLock Port Closed Vial Spike, ChemoLock, ChemoLock Port Bag Spike/CL3952; APPX 0.5ml, ChemoLock BAG SPIKE WITH ADDITIVE PORT,ChemoLock Port/CL3955;

Detalles del retiro

Fabricante

ICU Medical, Inc.

Distribuidor

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.

Lote

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

Clasificación de riesgo

Class II

Área (FDA)

device

País

United States