ICU Medical ChemoLock Bag Spike (REF CL-10-10) and 37 other ICU Medical ChemoLock products (for example REF CL-10, CL3011, CL3511, CL3929 and many others listed with UDIs and lot numbers) are being recalled. The port weld on these drug transfer devices may separate or break during use and potentially result in a leak.
What's being recalled
ChemoLock Bag Spike, 01 units REF: CL-10-10
ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10
ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS
ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150
ICU Medical 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Hanger, Drop-In Red Cap REF: CL3011
ICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, ChemoLock w/Red Cap, Bag Hanger REF: CL3511
ICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip Chamber, Spiros"; ChemoLock"; ChemoLock" Universal Vented Vial Spike; Bag Hanger REF: CL3929
ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940
ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136
ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port REF: CL4138
ICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer REF: CL4151
ICU Medical 60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, Spiros w/Red Cap REF: CL4173
ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap REF: CL4176
ICU Medical ChemoLock Bag Spike REF: CL-10
ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33
And 23 more products.
Recalling firm: ICU Medical, Inc., San Clemente, CA, United States.
How to identify it
UDI:10887709071022/Lot: 14397202 UDI:00887709070981/Lot: 14380109 UDI:00887709094505/Lot: 14407400 UDI:10887709094670/Lot: 14391937 UDI:10887709057019/Lot: 14386054 UDI:10887709057026/Lot: 14400616 UDI:10887709076768/Lot: 14400216, 14416769 UDI:10887709095295/Lot: 14406773 UDI:10887709096131/Lot: 14393176 UDI:10887709098388/Lot: 14400230 UDI:10887709123080/Lot: 14351926 UDI:10887709123356/Lot: 14332784 UDI:10887709056968/Lot: 14419330 UDI:10840619061729/Lot: 14393155, 14400613, 14376051 UDI:10887709057095/Lot: 14391971, 14395289 UDI:10887709067155/Lot:14379176 UDI:10887709062440/Lot:14385352, 14401250 UDI:10887709057125/Lot:14391976 UDI:10887709069593/Lot:14379182, 14391979, 14395300, 14401254, 14380121 UDI:10887709077116/Lot:14395313, 14393195, 14396054 UDI:10887709085692/Lot:14407453 UDI:10887709057002/Lot:14400191, 14379145 UDI:10887709071398/Lot:14397348, 14377757 UDI:10887709071411/Lot:14391954 UDI:10887709071411/Lot:14386086 14407433 Lot:14401659/ Distributed in France Lot:14385224; Distributed in Canada Lot:14400199; Distributed in Canada Lot:14407070,14384996,14391949; Distributed in Canada Lot:14393168, 14414091; Distributed in Canada Lot:14397353, 14418912; Distributed in Canada Lot:14369083 14386090 14391965; Distributed in Canada Lot:14393173, 14409213 ; Distributed in Canada Lot:14369087 ; Distributed in Canada Lot:14399518, 14399521, 14406408, 14399520, 14406410, 14406411 ; Distributed in Japan Lot:KL-VA001U3: 14360690 14345871 14367719 14381368 14381367; KL-VA002U3: 14345872; KL-VA131U3: 14381373; KL-VA201U3: 14337455 14381355 14381358; KL-VA202U3: 14367718, KL-VA321U3: 14345878 ; Distributed in Japan
The hazard
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)