—#83901

Product

SmartPort CT Port Access System, Catalog number CT80STPD, AngioDynamics Incorporated The SmartPort CT Port Access System is indicated for any patient requiring repeated access of the vascular system or other selected body site, for delivery of medications, nutritional supplementation, fluids, blood products, and sampling of blood.

FDA product code: LJT — Port & Catheter, Implanted, Subcutaneous, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K081472
Affected lot / code info: Lot number: 983533

Why it was recalled

The product may contain an incorrect size catheter and introducer.

Root cause (FDA determination)

Packaging process control

Action the firm took

Notification of the AngioDynamics, Inc. sales force began on July 16, 2009 and they were asked to assist in the return of all affected devices to the Manchester, GA division of AngioDynamics, Inc. Urgent Recall letters were sent to all customers on July 16, 2009, requesting the completion of a FAX BACK form. Those currently in possession of any remaining devices will be provided a Return Goods Authorization (RGA) number and pre-paid shipping boxes for return of the product to AngioDynamics, Inc. All returned devices will be physically and electronically quarantined until final disposition of the devices. All devices will be inspected for damage to the devices and any damaged devices destroyed (scrapped) via the AngioDynamics procedure for Disposition of Nonconformances, procedure. Non-damaged product may be reworked to remove the incorrect catheter and introducer and replaced with the correct catheter and introducer, repackaged and re-sterilized in accordance with the AngioDynamics procedure for Rework. If necessary, follow-up letters, phone calls or visits by the AngioDynamics sales representatives may be used to complete the effective checks. Level A (100%) of consignees to be contacted). Please contact your local representative or Recall Coordinator at 1-706-846-3126, for assistance. You may e-mail your questions to customerservice@angiodynamics.com.

Recalling firm

Firm: Angiodynamics, INC
Address: 1 Horizon Way, Manchester, Georgia 31816-1749

Distribution

Distribution pattern: AL, CA, CO, FL, GA, ID, IL, IN, KS, LA, MI, MO, MN, MS, NC, NY, OH, OR, PA, TN and TX.

Timeline

Recall initiated: 2009-07-16
Posted by FDA: 2009-09-01
Terminated: 2010-10-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #83901. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.