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.
This recall has been terminated (originally issued January 6, 2011).
- Company
- Bard Access Systems
- Recall Initiated
- December 10, 2010
- Posted
- January 6, 2011
- Terminated
- May 4, 2011
- Recall Number
- Z-0865-2011
- Quantity
- 195 units
- Firm Location
- West Salt Lake City, UT
- Official Source
- View on FDA website ↗
Reason for Recall
Prepackaged sterile latex gloves beyond their expiration date were packaged in surgical kits.
Distribution
Nationwide Distribution including AL, AZ, CA, GA, IA, MN, MO, NE, NJ, NY, OH, OR, SD, and WI.
Lot / Code Info
Lot numbers: REUF1011, REUF1303.
Root Cause
Employee error
Action Taken
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.