ARROW recallZ-1290-2022 · ARROW INTERNATIONAL Inc. · initiated May 5, 2022

Why it was recalled

Gravity flow rates on the affected product lidstock are incorrect.

FDA root cause category: Error in labeling

What the company is doing

A recall notification was issued to the consignee on 05/05/2022 via FedEx 2-day mail. The letter instructs the consignee to check the inventory, place a copy of the letter with all affected product and return the response form if the consignee is a medical facility. If the consignee is a distributor, the letter instructs the consignee to provide the notice to their customers, check the inventory, return the completed response form. An updated notification was sent on about 08/09/2022, via FedEx. The updated notification provided an additional description of the label error. Product scope remains the same.

Recall details

Recall number

Z-1290-2022

Status

Terminated

Initiated by the company

May 5, 2022

Posted by the FDA

Jun 27, 2022

Recalling firm

ARROW INTERNATIONAL Inc.

Quantity

10,301 units

Product code

FOZ

FDA submissions

K970864

Distribution

US Nationwide distribution in the states of Florida.

Product description

Arrow Three-Lumen CVC

Devices named in this recall

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

• ARROW IPN036097

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

Product lines

• ARROWTeleflex Incorporated · 1,494 models · 9,043 reports · 62 recalls

Other devices under the same FDA submission

9 devices cleared under K970864 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• ARROW IPN917020

  Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days
  2 recalls0 reports
• ARROW IPN917026

  Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days
  2 recalls0 reports
• ARROW IPN030066

  Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days
  1 death21 reports
• ARROW IPN030093

  Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days
  18 reports
• ARROW IPN033088

  Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days
  4 reports
• ARROW IPN036097

  Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days
  4 reports
• ARROW IPN033929

  Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days
  1 report
• ARROW IPN036098

  Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days
  1 report
• ARROW IPN036855

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