Class 2 Device Recall Groshong PICC

• Date Initiated by Firm: December 10, 2010
• Date Posted: January 06, 2011
• Recall Status: Terminated on May 04, 2011
• Recall Number: Z-0865-2011
• Recall Event ID: 57457
• 510(K)Number: K926331
• Product Classification: Catheter, intravascular, therapeutic, long-term greater than 30 days - Product Code LJS
• Product: Groshong 3 Fr. Single-Lumen PICC Intermediate Tray with Safety Introducer, Reorder Number 7717300, Bard Access Systems, Inc., Salt Lake City, UT 84116. The Groshong is a family of single and dual -lumen peripherally placed mid-line and central catheters made from specially formulated and processed medical grade materials, in a tray with accessories for reliable long (greater than 30 days) or short term (less than 30 days) vascular access.
• Code Information: Lot numbers: REUF1011, REUF1303.
• Recalling Firm/ Manufacturer: Bard Access Systems; 605 North 5600 West; Salt Lake City UT 84116-3738
• For Additional Information Contact: 801-522-5000
• Manufacturer Reason for Recall: Prepackaged sterile latex gloves beyond their expiration date were packaged in surgical kits.
• FDA Determined Cause: Employee error
• Action: BARD Access Systems sent an URGENT: GROSHON* 3 FR SINGLE-LUMEN PICC INTERMEDIATE TRAY WITH SAFETY INTRODUCER RECALL letter dated December 10, 2010. The letter identified the product, the problem,and the action to be taken by the customer. Customers were instructed to examine their inventory and quarantine the product subject to recall, discontinue use, and cease further distribution of any the affected product. If the product was further distributed, those customers were to be notified immediately with a copy of the recall notification letter. Any remaining product was to be returned to Bard. For information regarding this recall call 800-290-1689.
• Quantity in Commerce: 195 units
• Distribution: Nationwide Distribution including AL, AZ, CA, GA, IA, MN, MO, NE, NJ, NY, OH, OR, SD, and WI.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LJS