Recall archive / FDA device enforcement
Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10; ChemoLock BAG SPIKE w/ ADDITIVE PORT, DRY SPIKE/CL-... — FDA record Z-1681-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 27, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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;
- 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.
- Classification
- Class II
- Recalling firm
- ICU Medical, Inc.
- Quantity
- 454,635
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1681-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Sep 14, 2022
- Recall initiation date
- Jun 27, 2022
- Center classification date
- Sep 7, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.