Drug recall
HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous…
FDA recall event 80682 · Class II · Arrow International Inc
Key facts
| Event ID | 80682 |
|---|---|
| Recall numbers | Z-2818-2018, Z-2819-2018 |
| Recalling firm | Arrow International Inc |
| Product type | Devices |
| Products | HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14702 The central venous catheter permits venous…, HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14703 The central venous catheter permits venous… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The packaging may not be sealed. If the packaging is compromised in this manner, the sterility of the product cannot be guaranteed. |
| Initiation date | Jul 10, 2018 |
| Report date | Aug 22, 2018 |
| Termination date | May 27, 2020 |
| City | Reading |
| State | PA |
| Country | United States |
| FEI number | 2518433 |
At a glance
- 1–9 Products in this recall
- 1–9 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: