icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-80S.… recallZ-1093-2019 · 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-1093-2019

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

60500 devices

Product code

FPA

FDA submissions

K081361

Distribution

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

Product description

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 mechanically prohibits the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system during drug preparation and administration, thereby minimizing exposure of individuals, healthcare personnel and the environment to hazardous drugs.

Other devices under the same FDA submission

20 devices cleared under K081361 — 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 CH3025

  Icu Medical, Inc. · Set, administration, intravascular
  1 recall0 reports
• ICU Medical CH3035

  Icu Medical, Inc. · Set, administration, intravascular
  1 recall0 reports
• ICU Medical CH3322

  Icu Medical, Inc. · Set, administration, intravascular
  1 recall0 reports
• ICU Medical Z7107

  Icu Medical, Inc. · Set, administration, intravascular
  1 recall0 reports
• ICU Medical CL4001

  Icu Medical, Inc. · Set, administration, intravascular
  1 recall0 reports
• ICU Medical CH3639

  Icu Medical, Inc. · Set, administration, intravascular
  1 recall0 reports
• ICU Medical CH3731

  Icu Medical, Inc. · Set, administration, intravascular
  1 recall0 reports
• ICU Medical CH3581

  Icu Medical, Inc. · Set, administration, intravascular
  16 reports
• ICU Medical CH4000

  Icu Medical, Inc. · Set, administration, intravascular
  11 reports
• ICU Medical CH3943

  Icu Medical, Inc. · Set, administration, intravascular
  6 reports
• ICU Medical CH-72

  Icu Medical, Inc. · Set, administration, intravascular
  5 reports
• ICU Medical CV-100

  Icu Medical, Inc. · Set, administration, intravascular
  2 reports

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-1096-2019 · Terminated
  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 tran…