Drug recall
EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product Code:5905190, 14.5 Fr. Alphacurve Catheter with…
FDA recall event 83337 · Class II · Bard Peripheral Vascular Inc
Key facts
| Event ID | 83337 |
|---|---|
| Recall numbers | Z-2368-2019, Z-2369-2019, Z-2370-2019, Z-2371-2019, Z-2372-2019, Z-2373-2019, Z-2374-2019, Z-2375-2019, Z-2376-2019, Z-2377-2019, Z-2378-2019, Z-2379-2019 and 16 more |
| Recalling firm | Bard Peripheral Vascular Inc |
| Product type | Devices |
| Products | EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product Code:5905190, 14.5 Fr. Alphacurve Catheter with Standard Kit, 19 cm length, BARD, UDI# 00801741013799, EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product code:5905240, 14.5 Fr. Alphacurve Catheter with Standard Kit, 24cm length, BARD, UDI# 00801741013805, EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product code:5905280, 14.5 Fr. Alphacurve Catheter with Standard Kit, 28cm length, BARD, UDI# 00801741013812, EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903190, 14.5F, Straight ,19cm length, BARD, UDI# 00801741013690, EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903230, 14.5F, Straight ,23cm length, BARD, UDI: 00801741013706 and 23 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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. |
| Initiation date | May 31, 2019 |
| Report date | Sep 4, 2019 |
| Termination date | May 17, 2022 |
| City | Tempe |
| State | AZ |
| Country | United States |
| FEI number | 2020394 |
At a glance
- 10–99 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: