ChemoLock Close Vial Spike REF CL-80 recallZ-0652-2025 · ICU Medical, Inc. · initiated Nov 6, 2024

Why it was recalled

Due to finished goods incorrectly packaged and labeled.

FDA root cause category: Packaging process control

What the company is doing

On 11/06/2024, the firm send an "URGENT Medical Device Correction" Letter via third party (Sedgwick, Inc.) to customers informing them that product was incorrectly packaged and labeled. Product CL-80 package incorrectly contained product code CL-80S. The CL-80 is a used with a 20 mm or a 28 mm vial where as CL-80S is only use for a 20 mm vial. The issue is using the incorrect adapter may result in leakages. Actions to be taken by the Customer: Discontinue use mislabeled lot 13953938 of CL-80 and discard remaining product from this specific lot. 1. Check all inventory locations within your institution for the affected product listed in the notification and discontinue use. Quarantine and destroy all affected products following your institution s process for destruction. If destroying is not immediately possible at your facility, then the product should be quarantined until disposal. 2. Share this notification with all potential users of the device to ensure they are aware of this notification. If the devices are used at another location, please ensure this communication is delivered there./// 3. Complete and return the attached Customer Response Form to [email protected] within 10 days of receipt to acknowledge your understanding of this notification./ / 4. DISTRIBUTORS: If you have distributed affected products to your customers, please immediately forward this notice to them. Request that they complete the response form and return it to [email protected]. For questions/assistance, contact: Global Complaint Management 1-844-654-7780 (M-F, 8:00am 5:00pm CT) or [email protected] To report adverse events or product complaints Customer Service 1-866-829-9025, option 8 or [email protected] (M-F, 8:00 am 6:00 pm CT) Additional information or to request a credit. Field Action Processing 1-888-843-0245 [email protected] Questions about this communication

Recall details

Recall number

Z-0652-2025

Status

Open, Classified

Initiated by the company

Nov 6, 2024

Posted by the FDA

Dec 9, 2024

Recalling firm

ICU Medical, Inc.

Quantity

6000 units

Product code

ONB

FDA submissions

K131549

Distribution

Worldwide - U.S. Nationwide distribution in the state of IL and the country of Canada.

Product description

ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents the transfer of environmental contaminants. The Chemolock is needle free and cannot be deactivated, which will passively aid in preventing needlestick injuries and the exposure to cytotoxic medications for healthcare personnel.

Devices named in this recall

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

• ICU Medical CL-80

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

Other devices under the same FDA submission

90 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 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 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