Two-Lumen Central Venous Catheterization Kit with Blue… recallZ-0786-2010 · Arrow International Inc · initiated Nov 24, 2009

Why it was recalled

Q-Syte Component contained in kits was recalled by manufacturer due to the potential for embolism if used with a central venous catheter.

FDA root cause category: Nonconforming Material/Component

What the company is doing

The recalling firm issued an Urgent Medical Device Recall letter dated 11/24/09 to their customers informing them of the problem the need to return any kits in inventory and notify their customers of the recall. For additional information customers can contact the Customer Service Department at 800-523-8446.

Recall details

Recall number

Z-0786-2010

Recall class

Not yet classified by the FDA

Status

Terminated

Initiated by the company

Nov 24, 2009

Posted by the FDA

Mar 5, 2010

Recalling firm

Arrow International Inc

Quantity

20 kits

Product code

FOZ

FDA submissions

K993691

Distribution

The products were shipped to distributors in GA, MD, and VA.

Product description

Two-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R), ARROWg+ard Blue PLUS (R) Catheter, Sharps Safety Features and Maximal Barrier Precautions. The product is shipped in cases containing 5 catheters (contains Q-Syte)

Other devices under the same FDA submission

14 devices cleared under K993691 — 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 IPN037069

  Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days
  1 recall0 reports
• ARROW IPN037833

  Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days
  1 recall0 reports
• ARROW IPN037836

  Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days
  1 recall0 reports
• ARROW IPN038392

  Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days
  1 recall0 reports
• ARROW IPN055804

  Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days
  1 recall0 reports
• ARROW IPN916999

  Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days
  1 recall0 reports
• ARROW IPNB00080

  Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days
  1 recall0 reports
• ARROW IPN030243

  Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days
  20 reports
• ARROW IPN030195

  Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days
  3 reports
• ARROW IPN030240

  Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days
  1 report
• ARROW IPN030231

  Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days
  1 report
• ARROW IPN037089

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

Other products in the same recall event

The FDA groups related products into one recall event (event 53954).

• Z-0783-2010 · Terminated
  MAC (TM) Two Lumen Central Venous Access Kit with ARROWg+ard Blue (R) Access Device, Integral Hemostasis Valve, Sharps Safety Features and Maximal Barrier Precautions for use with …
• Z-0784-2010 · Terminated
  Percutaneous Sheath Introducer Kit with ARROWg+ard Blue (R) Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8…
• Z-0785-2010 · Terminated
  Multi-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R), ARROWg+ard Blue PLUS (R) Catheter, Sharps Safety Features and Maximal Barrier Precautions. The product is ship…
• Z-0787-2010 · Terminated
  Multi-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R), ARROWg+ard Blue PLUS (R) Catheter, Sharps Safety Features and Maximal Barrier Precautions. (contains Q-Syte)
• Z-0788-2010 · Terminated
  Multi-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R), ARROWg+ard Blue PLUS (R) Catheter, Sharps Safety Features and Maximal Barrier Precautions. (contains Q-Syte)