Arrow International, Inc. 7FR 3-Lumen Arrowg+ard Blue… recallZ-1823-2012 · Arrow International Inc · initiated Jun 7, 2012

Why it was recalled

Arrow is recalling the product due to the possibility of voids in the catheter hub which could lead to an interlumen crossover.

FDA root cause category: Nonconforming Material/Component

What the company is doing

Arrow International sent a Urgent Medical Device Recall Notification letter dated June 11, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to take the following action: 1. If you have affected stock, immediately discontinue use and quarantine any products with the catalog and lot numbers listed. 2. To return product complete the enclosed Recall Acknowledgement Form and fax to 1-800-343-2935, Attn: Customer Service. This will allow us to document the amount of the product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization ( RGA) Number and will provide instructions for the return of product to Arrow International. 3. If you have no affected stock, please complete t he enclosed Recall Acknowledgment Form and fax it to 1-800-343-2935, Attn: Customer Service. This will allow us to document your receipt of this letter. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-800-343-2935.

Recall details

Recall number

Z-1823-2012

Recall class

Class II

Status

Terminated

Initiated by the company

Jun 7, 2012

Posted by the FDA

Jun 19, 2012

Recalling firm

Arrow International Inc

Quantity

1,085

Product code

FOZ

FDA submissions

K071538

Distribution

USA (nationwide) AL, AZ, AR, CA, CO, FL, GA, IL, IN, KS, LA, MA, MI, MO, NV, NH, NC, OH, PA, TX, VA, WA, and WI.

Product description

Arrow International, Inc. 7FR 3-Lumen Arrowg+ard Blue Plus(R) Pressure Injectable Central Venous Catheter - Catalog number CDC-42703-XP1A The multiple-lumen pressure injectable catheter permits venous access to central circulation and injection of contrast media. The ARROWg+ard(R) antimicrobial surface is intended to provide protection against catheter-related infections.

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