Pressure Injectable Multi- Lumen Central Venous… recallZ-1162-2018 · Arrow International Inc · initiated Nov 14, 2017

Why it was recalled

Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions.

FDA root cause category: Labeling mix-ups

What the company is doing

On November 16, 2017, an Urgent Medical Device Notification titled "ARROW PSI and Pressure Injectable Multi-Lumen CVC Kits" was issued to customers informing them of the issue, and urging all to take the following actions: 1. Place a copy of this notification and the enclosed Central Line Insertion Checklist with each unit of affected product currently in your inventory. 2. Complete the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or e-mail to [email protected]. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.

Recall details

Recall number

Z-1162-2018

Recall class

Class II

Status

Terminated

Initiated by the company

Nov 14, 2017

Posted by the FDA

Mar 5, 2018

Recalling firm

Arrow International Inc

Quantity

18,124 total

Product code

FOZ

FDA submissions

K071538

Distribution

Nationwide Distribution

Product description

Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter and Sharps Safety Features. Permits venous access to central circulation.

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 79342).

• Z-1158-2018 · Terminated
  Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters. Permits ven…
• Z-1159-2018 · Terminated
  Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter, Sharps Safety Features and Maximal Barrier Precautions. Permits venous access and c…
• Z-1160-2018 · Terminated
  Percutaneous Sheath Introducer Kit with ARROWg+ard Blue Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr…
• Z-1161-2018 · Terminated
  Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features, and Maximal Barrier Precautions.…
• Z-1163-2018 · Terminated
  Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter, Sharps Safety Features and Maximal Barrier Precautions. Permi…
• Z-1164-2018 · Terminated
  Pressure Injectable Two- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter and Sharps Safety Features. Permits venous access to central cir…
• Z-1165-2018 · Terminated
  Pressure Injectable Multi- Lumen CVC Kit
• Z-1166-2018 · Terminated
  ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kit. Intended to permit venous access to the central circulation.