icumedical ChemoLock Vial Spike, 20mm, REF CL-80S recallZ-0805-2019 · ICU Medical, Inc. · initiated Jan 3, 2019

Why it was recalled

There is a potential for one lot of ChemoLock Vial Spike to contain burr particulate

FDA root cause category: Vendor change control

What the company is doing

On 01/03/2019, Stericycle, Inc. sent an " URGENT: MEDICAL DEVICE RECALL" notification of the recall to ICU Medical direct consignees of record via traceable mailing. Consignees who further distributed the product were asked to notify their customers. The notification described the product, problem and actions to be taken. The consignees were instructed to do the following: 1)Please discontinue the use and distribution of the affected product immediately. Check your inventory and quarantine all affected product at your facility. 2) Inform potential users of the product in your organization of this notification and complete the attached response form. Return the completed response form to the fax number or e-mail address on the form, even if you do not have the affected product. 3) Return affected product using the return label provided with this letter. Contact Stericycle at 1-888-871-7114 (M-F, 8am-5pm ET) if you have not received a return label or require additional labels for returning the affected product. The return labels are for single use only. Please do not reproduce. Please visit http://expertezlabel.com to request additional labels for returning affected product. To ensure proper and timely credit, follow the instructions on the return label for returning product. Upon receipt of the completed response form and return of the affected product, ICU Medical will credit you for any product returned. 4) If you have distributed the product further, immediately notify your accounts that received the product identified in the Affected Product/ Table 1 sections of this notification and ask them to contact Stericycle at 1-888-871-7114 (M-F, 8am-Spm ET) to obtain a response form. For further inquiries, including product replacement options, please contact ICU Medical using the information provided below. Global Complaint Management at 1-844-654-7780 or email to: ([email protected]) To report adverse events or product complaints or

Recall details

Recall number

Z-0805-2019

Recall class

Class I (most serious)

Status

Terminated

Initiated by the company

Jan 3, 2019

Posted by the FDA

Feb 22, 2019

Recalling firm

ICU Medical, Inc.

Quantity

2050 units

Product code

ONB

FDA submissions

K131549

Distribution

US Distribution to states of: OH, FL, IA, CA, PA, IL, VA; and internationally to: AUSTRIA, CHINA (TAIWAN), IRELAND, ITALY and SINGAPORE.

Product description

icumedical ChemoLock Vial Spike, 20mm, REF CL-80S The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system.

Other devices under the same FDA submission

91 devices cleared under K131549 — the recall does not name any of them by identifier. 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 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