ARROW PICC Kit featuring Chlorag+ard Technology recallZ-0207-2016 · Arrow International Inc · initiated Oct 16, 2015

Why it was recalled

Possibility that the catheter peel-away component hub tabs may prematurely detach when the practitioner begins to peel apart the sheath body from the catheter. Although the issue does not pose a significant risk to the patient, it may cause a delay of treatment when placing the catheter.

FDA root cause category: Unknown/Undetermined by firm

What the company is doing

Arrow International sent an Urgent Medical Device Recall Notification letter dated October 16, 2015, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignees. Consignees were instructed to immediately discontinue use and quarantine any effected products. Consignees were instructed to return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507 Attn: Customer Service or email it to [email protected]. A customer service representative will contact consignees with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Arrow International. For consignees with no affected product, should also complete the enclosed Recall Acknowledgement Form. For questions customers should call 1-866-246-6990.

Recall details

Recall number

Z-0207-2016

Recall class

Class II

Status

Terminated

Initiated by the company

Oct 16, 2015

Posted by the FDA

Nov 4, 2015

Recalling firm

Arrow International Inc

Quantity

12,157

Product code

LJS

FDA submissions

K112896, K113277, K121941, K122854, K132133

Distribution

World Wide Distribution - US including AR, AL, TX, MA, CA, IA, MO, NY, AL, VA, RI, IN, TN, FL, KY, NH, SC, MD, WA, OK, IL, ME, OR, OH, PA, MI, KS, LA, TN, WV, NE, NJ, NV, GA, SD, CT, MS, CO, and Internationally to Canada and Belgium.

Product description

ARROW PICC Kit featuring Chlorag+ard Technology Midline Catheterization Kit ARROW Advantage5 Pressure Injectable PICC Kit Arrow Pressure Injectable Arrow PICC powered by Arrow VPS Stylet ARROW Pressure Injectable JACC with Chlorag+ard Technology For short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring. Permits venous access to the peripheral circulation. Offers an alternative method of intravenous access for select adult and pediatric patients. The ARROW GlideThru Peel-Away Sheath/Dilator is used for the percutaneous introduction of diagnostic or therapeutic devices into the vasculature.

Other devices under the same FDA submission

63 devices cleared under K112896, K113277, K121941, K122854, K132133 — 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 IPN924180

  Teleflex Incorporated · Catheter, intravascular, therapeutic, long-term greater than 30 days
  2 recalls0 reports
• ARROW IPN924181

  Teleflex Incorporated · Catheter, intravascular, therapeutic, long-term greater than 30 days
  2 recalls0 reports
• ARROW IPN033424

  Teleflex Incorporated · Catheter,intravascular,therapeutic,long-term greater than 30 days
  70 reports
• ARROW IPN924163

  Teleflex Incorporated · Catheter, intravascular, therapeutic, long-term greater than 30 days
  1 recall8 reports
• ARROW IPN924157

  Teleflex Incorporated · Catheter, intravascular, therapeutic, long-term greater than 30 days
  1 recall5 reports
• ARROW IPN924159

  Teleflex Incorporated · Catheter, intravascular, therapeutic, long-term greater than 30 days
  1 recall4 reports
• ARROW IPN924178

  Teleflex Incorporated · Catheter, intravascular, therapeutic, long-term greater than 30 days
  1 recall2 reports
• ARROW IPN919384

  Teleflex Incorporated · Catheter, intravascular, therapeutic, long-term greater than 30 days
  1 recall0 reports
• ARROW IPN919534

  Teleflex Incorporated · Catheter, intravascular, therapeutic, long-term greater than 30 days
  1 recall0 reports
• ARROW IPN919553

  Teleflex Incorporated · Catheter, intravascular, therapeutic, long-term greater than 30 days
  1 recall0 reports
• ARROW IPN924162

  Teleflex Incorporated · Catheter, intravascular, therapeutic, long-term greater than 30 days
  1 recall0 reports
• ARROW IPN928624

  Teleflex Incorporated · Catheter, intravascular, therapeutic, long-term greater than 30 days
  1 recall0 reports