83" (211 cm) Appx 10.3 mL, 60 Drop Primary Set w/BCV-Clave… recallZ-2621-2014 · ICU Medical, Inc. · initiated Aug 19, 2014

Why it was recalled

ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended.

FDA root cause category: Nonconforming Material/Component

What the company is doing

ICU Medical sent an Urgent Medical Device Recall letter dated August 19, 2014 to all affected customers. The letter identified the affected product, problems identified and the actions to be taken. Customers were instructed to complete the recall response form and fax to ICU Medical at (801) 264-1755 or by email: [email protected]. Customers with questions or require assistance relating to this recall were instructed to contact ICU Customer Service Monday through Friday between the hours of 8:30 AM and 4:00 PM Pacific time: 866-829-9025 and select option 8, or e-mail the following address: [email protected]. For questions regarding this recall call 801-264-1732.

Recall details

Recall number

Z-2621-2014

Recall class

Class I (most serious)

Status

Terminated

Initiated by the company

Aug 19, 2014

Posted by the FDA

Sep 19, 2014

Recalling firm

ICU Medical, Inc.

Quantity

100 units

Product code

FMG

FDA submissions

K964435

Distribution

Worldwide Distribution - US (nationwide) in the state of WA, OR and the country of South Africa.

Product description

83" (211 cm) Appx 10.3 mL, 60 Drop Primary Set w/BCV-Clave, Stat 2 Flow Controller, Clave, Rotating Luer, Item No. B9897. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.

Other devices under the same FDA submission

563 devices cleared under K964435 — 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 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 69088).

• Z-2619-2014 · Terminated
  STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 20 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9801. Product Usage: IV Administration sets …
• Z-2620-2014 · Terminated
  STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 60 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9802. Product Usage: IV Administration sets …
• Z-2622-2014 · Terminated
  98" (249 cm) Appx 12.3 ml, 60 Drop Primary Set w/Pre-Slit Port, STAT 2 Flow Controller, Rotating Luer, Item No. Z2648. Product Usage: IV Administration sets are intended for the i…