icumedical ChemoLock, 20mm recallZ-1096-2019 · ICU Medical, Inc. · initiated Feb 21, 2019

Why it was recalled

There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the assembly of the device.

FDA root cause category: Vendor change control

What the company is doing

The firm, Icumedical, initiated the recall by "URGENT: MEDICAL DEVICE RECALL" letter on 02/21/2019 to its customers. The letter described the product, problem and actions to be taken. The customers 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 via fax to: 1-855-497-9856 or email to: [email protected], 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. 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-5pm ET) to obtain a response form. UPDATED INFORMATION: On 03 January 2019, ICU Medical, Inc. issued an Urgent Medical Device Recall letter informing customers of a recall of one lot (3757712) of the ChemoLock" Vial Spike, 20mm (CL-80S). As a result of continued evaluation, ICU Medical is expanding the scope of the previously distributed Urgent Medical Device Recall to include certain lots of ChemoLock" and ChemoClave Vial Spikes that may also be affected by this issue. All product lots identified in this communication are impacted by this recall. If you have any questions, please contact Customer Care at 1- 877-946-7747 General inquires /Product replacement options.

Recall details

Recall number

Z-1096-2019

Recall class

Class I (most serious)

Status

Terminated

Initiated by the company

Feb 21, 2019

Posted by the FDA

Apr 15, 2019

Recalling firm

ICU Medical, Inc.

Quantity

160775 devices

Product code

FPA

FDA submissions

K131549

Distribution

Worldwide distribution: US nationwide and countries of: Canada, France, and Singapore.

Product description

icumedical ChemoLock, 20mm, (a) REF CL-80S (b) REF CL-80S-10 (10 units). Used in IV administration sets. 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. The ChemoLock is needlefree and cannot be deactivated, which will passively aid in preventing needlestick injuries and the exposure to cytotoxic medications for healthcare personnel.

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

Other products in the same recall event

The FDA groups related products into one recall event (event 82291).

• Z-1092-2019 · Terminated
  icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-70S . Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanica…
• Z-1093-2019 · Terminated
  icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-80S. Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanical…