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U.S. Department of Health and Human Services

Class 2 Device Recall Groshong PICC

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  Class 2 Device Recall Groshong PICC see related information
Date Initiated by Firm December 10, 2010
Date Posted January 06, 2011
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = BARD ACCESS SYSTEMS, INC.
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