Recall Z-0865-2011 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Bard Access Systems
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
| Date | Jan 6, 2011 (initiated Dec 10, 2010) |
| Status | Terminated |
| Reason | Prepackaged sterile latex gloves beyond their expiration date were packaged in surgical kits. |
| Root 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 |
| Quantity | 195 units |
| Distribution | Nationwide Distribution including AL, AZ, CA, GA, IA, MN, MO, NE, NJ, NY, OH, OR, SD, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K926331 | 3.0 FR GROSHONG PERIPHER INSERT CENT VENOUS CATH Bard Access Systems, Inc., Mar 7, 1994 |