REF MC330209 6' (15 cm) Appx 0.09 ml, Smallbore Trifuse Ext… recallZ-0511-2021 · ICU Medical, Inc. · initiated Jul 1, 2020

Why it was recalled

Incorrect filter assemblies in IV administration set.

FDA root cause category: Component design/selection

What the company is doing

On 07/01/2020, the firm sent an Urgent: Medical Device Recall" to customers via mail, by third party to inform them that the firm has become aware that there is a potential problem related to the IV administration set with incorrect filter, which may result in delay in therapy, contamination or particulate embolism. This recall affected specific lots. The firm is instructing customers to discontinue the use, distribution and quarantine the products, print the return label from http://expertezlabel.com and return the affected devices to third party contracted service and if questions, to contact [email protected] or 1-844-654-7780 for adverse event or complaints and for additional assistance, to call 1-866-829-9025, option 8 or [email protected]. .

Recall details

Recall number

Z-0511-2021

Status

Terminated

Initiated by the company

Jul 1, 2020

Recalling firm

ICU Medical, Inc.

Quantity

1100 units

Product code

FMG

FDA submissions

K964435

Distribution

U.S. Nationwide distribution including in the states of WI, MA, CA, FL, MN, IL, NY.

Product description

REF MC330209 6' (15 cm) Appx 0.09 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 0.2 Micron Filter, 1.2 Micron Filter, 3 Clamps (Blue, Yellow, White), Rotating Luer - 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 catheter (which is inserted into a vein). Directions for Use: icumedical IV Extension Sets Clave/MicroClave/NanoClave Connectors Antimicrobial Clave/MicroClave Connectors Spiros Closed Male Luer.

Devices named in this recall

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

• ICU Medical MC330209

  Icu Medical, Inc. · Stopcock, i.V. Set
  1 recall1 death1 report

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