Recall Z-2209-2020 ยท MSD Catheter, Hemodialysis, Implanted
Bard Peripheral Vascular Inc
EQUISTREAM XK Long-Term Hemodialysis Catheter. REF/UDI:5913190/(01)00801741013836; 16F
| Date | Jun 14, 2019 |
| Status | Terminated |
| Reason | Incorrect Peel-Apart Introducer Sheath in Kit. |
| Root cause | Error in labeling |
| Action | On 06/14/2019, an URGENT MEDICAL DEVICE RECALL NOTIFICATION letter was sent to each of the US consignees via FedEx with proof of delivery notification. |
| Quantity | 400 |
| Distribution | 67 US Consignees. US - AL, AR, AZ, CA, FL, GA, IA, ID, IL, KY, LA, MD, MN, MT, NC, NY, OR, PA, TN, TX, VA, WA, WI and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090901 | ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING TEST, ESENSOR INSTRUMENT, MODELS XT-8 Osmetech Molecular Diagnostics, Jul 6, 2009 |