Product Description/Item: ChemoLock Bag Spike, 10… recallZ-1681-2022 · ICU Medical, Inc. · initiated Jun 27, 2022

Why it was recalled

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.

FDA root cause category: Component design/selection

What the company is doing

On 06/27/2022 recall notices were mailed to customers who were asked to do the following: 1) Discontinue the use and distribution of the affected product immediately. Check your inventory and quarantine all affected product at your facility. 2) In instances where the benefits of using the ChemoLock are greater than the potential risks for non-connection or disconnection, and you choose to utilize ChemoLock affected lot numbers, ensure full engagement between the ChemoLock Port and ChemoLock Injector. If full engagement is achieved, the device will work as intended. If full engagement cannot be achieved or is difficult to achieve, discard product and utilize a new device. 3) Complete and return the response form. 4) The recalling firm's customer service can be contacted for product availability information. 5) Return affected product using the return label provided. Contact Sedgwick if you have not received a return label or require additional labels. 6) If you have distributed the product further, immediately notify your accounts and ask them to contact Sedgwick. For further inquiries, please contact: Global Complaint Management 1-844-654-7780 or [email protected]; Customer Service 1-866-829-9025, option 8 or [email protected]; Sedgwick 1-888-943-5190 (M-F, 8am-5pm ET)

Recall details

Recall number

Z-1681-2022

Status

Open, Classified

Initiated by the company

Jun 27, 2022

Recalling firm

ICU Medical, Inc.

Quantity

454,635

Product code

ONB

FDA submissions

K131549

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.

Product description

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;

Devices named in this recall

49 devices in the FDA device registry whose identifier appears in the recall's code information.

• ICU Medical CL3011

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  3 recalls26 reports
• ICU Medical CL3511

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  3 recalls6 reports
• ICU Medical CL4136

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  3 recalls1 report
• ICU Medical CL-80

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  3 recalls0 reports
• ICU Medical CL3900

  Icu Medical, Inc. · Set, administration, intravascular
  3 recalls0 reports
• ICU Medical CL3960

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  2 recalls26 reports
• ICU Medical CL4130

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  2 recalls6 reports
• ICU Medical CL4131

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  2 recalls6 reports
• ICU Medical CL-80S

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  2 recalls5 reports
• ICU Medical CL-82

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  2 recalls3 reports
• ICU Medical CL-80S-5

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  2 recalls2 reports
• ICU Medical CL-72

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  2 recalls1 report
• ICU Medical CL-70S

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  2 recalls1 report
• ICU Medical CL-10-10

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  2 recalls1 report
• ICU Medical CL-70

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  2 recalls0 reports
• ICU Medical CL-70-10

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  2 recalls0 reports
• ICU Medical CL2150

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  2 recalls0 reports
• ICU Medical CL3528

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall8 reports
• ICU Medical CLH-12

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall8 reports
• ICU Medical CL-13

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall6 reports
• ICU Medical CL3955

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall6 reports
• ICU Medical CL-12

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall3 reports
• ICU Medical CL3538

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall3 reports
• ICU Medical CL4146-5

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall1 report
• ICU Medical CL2100T

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall1 report
• ICU Medical CL-80S-10

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall0 reports
• ICU Medical CL-62

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall0 reports
• ICU Medical CL-80SL

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall0 reports
• ICU Medical CL-34

  Icu Medical, Inc. · Set, administration, intravascular
  1 recall0 reports
• ICU Medical CL-70S-5

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall0 reports
• ICU Medical CL3364

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall0 reports
• ICU Medical CL3927

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall0 reports
• ICU Medical CL3946

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall0 reports
• ICU Medical CL3947

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall0 reports
• ICU Medical CL3952

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall0 reports
• ICU Medical CL3963

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall0 reports
• ICU Medical CL4114

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall0 reports
• ICU Medical CL4143

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall0 reports
• ICU Medical CL4153

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall0 reports
• ICU Medical CL-70-10T

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall0 reports
• ICU Medical CL-70T

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall0 reports
• ICU Medical CL-72T

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall0 reports
• ICU Medical CL3535T

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall0 reports
• ICU Medical CL3511T

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall0 reports
• ICU Medical CL-80S-10T

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall0 reports
• ICU Medical CL4159

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall0 reports
• ICU Medical CL-76

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall0 reports
• ICU Medical CL2100-5

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall0 reports
• ICU Medical CL4179

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall0 reports

Other devices under the same FDA submission

42 devices cleared under K131549 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• ICU Medical CL3929

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  2 recalls0 reports
• ICU Medical CL2100

  Icu Medical, Inc. · Set, administration, intravascular
  1 recall32 reports
• ICU Medical CL-10

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall16 reports
• ICU Medical CL3940

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall9 reports
• ICU Medical CL3520

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall3 reports
• ICU Medical CL4151

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall1 report
• ICU Medical CL-33

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall0 reports
• ICU Medical CL3360

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall0 reports
• ICU Medical CL3294

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall0 reports
• ICU Medical CL3978

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall0 reports
• ICU Medical CL4100

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall0 reports
• ICU Medical CL3020T

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall0 reports