Recall Z-2395-2019 ยท MSD Catheter, Hemodialysis, Implanted
Bard Peripheral Vascular Inc
GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397500, 14.5F, straight, 50cm length, BARD, UDI: 00801741012358
| Date | May 31, 2019 |
| Status | Terminated |
| Reason | The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter. |
| Root cause | Nonconforming Material/Component |
| Action | Bard Peripheral Vascular, Inc. (BPV) mailed a recall letter on May 23, 2019 to each of the US consignees via FedEx with proof of delivery notification. BPV is also issuing customer notifications for product outside the US in accordance with regulations of each country in which the product was distributed. The recall letter asked consignees to do the following: 1. Do not use or further distribute any affected product. 2. Please check all inventory locations within your institution for affected product code / lot number combinations listed in the recall notice. If you have further distributed |
| Quantity | 140 units |
| Distribution | US: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA,MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY OUS: Australia, Canada, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051748 | HEMOGLIDE SERIES AND HEMOGLIDE STAR SERIES XK LONG-TERM HEMODIALYSIS CATHETERS C.R. Bard, Inc., Aug 12, 2005 |