7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER… recallZ-0957-2021 · ICU Medical, Inc. · initiated Dec 2, 2020

Why it was recalled

Due to the incorrect filter assembly.

FDA root cause category: Process control

What the company is doing

On 12/02/2020, the firm's third party contractor send an "URGENT: MEDIAL DEVICE RECALL" Notification letter via traceable mailing to direct and indirect consignees informing them that specific lots of IV extension sets that may contain an incorrect filter assembly of a 0.2 micron filter instead of a 1.2 micron filter and the potential hazards/risks potentially cause delay in therapy or under delivery of medication. Customers are instructed to: 1) Discontinue the use and distribution of the affected product immediately. Check inventory and quarantine all affected product at their facility. 2) Inform potential users of the product in their organization of the notification and to complete the attached response form. Return the completed response form to the fax number or e-mail address on the form, even if customer do not have the affected product. 3) Return affected product using the return label provided with the letter. Contact Stericycle at 1-888-243-5547 (MF, 8am-5pm ET) if they 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. 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, the Recalling Firm will credit you for any product returned. Customers will only receive credit for product that they return. NOTE: Credits for product purchased through distributor will be credited by the distributor. 4) If customers have distributed the product further, immediately notify the accounts that received the product identified in the Affected Product section of this notification and ask them to contact Stericycle at 1-888-243-5547 (M-F, 8am-5pm ET) to obtain a response form. For further inquiries, please contact the Recalling Firm usi

Recall details

Recall number

Z-0957-2021

Status

Terminated

Initiated by the company

Dec 2, 2020

Recalling firm

ICU Medical, Inc.

Quantity

Total Kits = 7,500 for all four lots

Product code

FMG

FDA submissions

K964435

Distribution

Worldwide distribution - U.S. Nationwide distribution including in the states of AZ, CA, CO, CT, FL, ID, IL, LA, MA, MN, NC, NJ, NY, TN, TX, VA, WA and WV. The country of Belgium.

Product description

7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

Devices named in this recall

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

• ICU Medical Z3532

  Icu Medical, Inc. · Stopcock, i.V. Set
  1 recall0 reports

Other devices under the same FDA submission

562 devices cleared under K964435 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• ICU Medical AC135

  Icu Medical, Inc. · Stopcock, i.V. Set
  1 recall10 reports
• ICU Medical MC330174

  Icu Medical, Inc. · Stopcock, i.V. Set
  1 recall4 reports
• ICU Medical Z2587

  Icu Medical, Inc. · Stopcock, i.V. Set
  1 recall3 reports
• ICU Medical B90111

  Icu Medical, Inc. · Stopcock, i.V. Set
  1 recall2 reports
• ICU Medical B9535

  Icu Medical, Inc. · Stopcock, i.V. Set
  1 recall2 reports
• ICU Medical B9650

  Icu Medical, Inc. · Stopcock, i.V. Set
  1 recall2 reports
• ICU Medical Z3239

  Icu Medical, Inc. · Stopcock, i.V. Set
  1 recall2 reports
• ICU Medical Z3626

  Icu Medical, Inc. · Stopcock, i.V. Set
  1 recall2 reports
• ICU Medical MRSA60-84

  Icu Medical, Inc. · Stopcock, i.V. Set
  1 recall2 reports
• ICU Medical AM3020

  Icu Medical, Inc. · Stopcock, i.V. Set
  1 recall2 reports
• ICU Medical B33971

  Icu Medical, Inc. · Stopcock, i.V. Set
  1 recall2 reports
• ICU Medical B3065

  Icu Medical, Inc. · Stopcock, i.V. Set
  1 recall1 report

Other products in the same recall event

The FDA groups related products into one recall event (event 86973).

• Z-0955-2021 · Terminated
  60 IN (152cm) APPX 1.5 ml, PUR YELLOW SMALLBORE SET, FILTER REF B2209 - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which pr…
• Z-0956-2021 · Terminated
  60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave Clear, 1.2 Micron Filter, 2 Clamps, Luer Lock REF MC330174 - Product Usage: The intravascular administration set is a singl…
• Z-0958-2021 · Terminated
  154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides ac…