Multi-Lumen PI CVC Kit and PSI Kit: 3-L 7 FR X 8 product… recallZ-1005-2015 · Arrow International Inc · initiated Dec 16, 2014

Why it was recalled

the Instructions for Use (IFU) were inadvertently removed from the kit.

FDA root cause category: Labeling False and Misleading

What the company is doing

An Urgent Medical Device Corrective Action Notification letter, dated December 16, 2014, was sent to Owens & Minor, 1605 Worldwide Blvd., Hebron, KY 41048-8653, instructing them to immediately discontinue distribution and quarantine any products, use customer letter and Corrective Action Acknowledgement Form templates to communicate this corrective action to any of thier customers that have received product included within the scope of the corrective action, and to have their customers return a completed Corrective Action Acknowledgement Form outlining their remaining inventory of the affected product codes and lot numbers for which replacement IFUs is needed.

Recall details

Recall number

Z-1005-2015

Recall class

Class II

Status

Terminated

Initiated by the company

Dec 16, 2014

Posted by the FDA

Jan 22, 2015

Recalling firm

Arrow International Inc

Quantity

420

Product code

FOZ

FDA submissions

K071538

Distribution

In the state of KY

Product description

Multi-Lumen PI CVC Kit and PSI Kit: 3-L 7 FR X 8 product code: ASK-45703-POSU lot #23F13L0166, exp. 31-Jul-2015: Product Usage: Multi-Lumen PI CVC Kit: An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patients vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials. PSI Kit: A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

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