Multi-Lumen Pressure Injectable Central Venous… recallZ-2491-2010 · Arrow International Inc · initiated Jul 29, 2010

Why it was recalled

Incorrectly assembled 18 Ga x 2 1/2 Introducer Needle

FDA root cause category: Mixed-up of materials/components

What the company is doing

The recalling firm issued an Urgent Medical Device Recall letter dated 7/23/2010 along with a a recall acknowledgement and stock status form.

Recall details

Recall number

Z-2491-2010

Recall class

Not yet classified by the FDA

Status

Terminated

Initiated by the company

Jul 29, 2010

Posted by the FDA

Sep 25, 2010

Recalling firm

Arrow International Inc

Product code

FOZ

FDA submissions

K071538

Distribution

The product was shipped to medical centers and hospitals nationwide and to Australia, New Zealand, and Europe.

Product description

Multi-Lumen Pressure Injectable Central Venous Catheterization kit with Blue FlexTip Catheter, ARROW g+ard Blue PLUS Catheter and Sharps Safety Features

Other devices under the same FDA submission

231 devices cleared under K071538 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• ARROW IPN038522

  Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days
  3 recalls1 report
• ARROW IPN931283

  Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days
  3 recalls0 reports
• ARROW IPN931284

  Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days
  3 recalls0 reports
• ARROW IPN931286

  Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days
  3 recalls0 reports
• ARROW IPN036445

  Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days
  2 recalls8 reports
• ARROW IPN915628

  Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days
  2 recalls5 reports
• ARROW IPN915630

  Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days
  2 recalls2 reports
• ARROW IPN036474

  Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days
  2 recalls1 report
• ARROW IPN904896

  Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days
  2 recalls1 report
• ARROW IPN038523

  Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days
  2 recalls1 report
• ARROW IPN055818

  Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days
  2 recalls1 report
• ARROW IPN055820

  Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days
  2 recalls1 report

Other products in the same recall event

The FDA groups related products into one recall event (event 56363).

• Z-2488-2010 · Terminated
  MAC Two-Lumen Central Venous Access kit with Integral Hemostasis Valve for use with 7 - 8 Fr. Catheters
• Z-2493-2010 · Terminated
  Two-Lumen Central Venous Catheterization kit with Blue FlexTip ARROW g+ard Blue PLUS Catheter, Sharps Safety Features, and Maximal Barrier Precautions
• Z-2494-2010 · Terminated
  Arterial Catheterization Set
• Z-2495-2010 · Terminated
  Femoral Artery Catheterization Set
• Z-2496-2010 · Terminated
  Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter