Drug recall
14F x 20CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061423 Product Usage…
FDA recall event 83324 · Class II · Medical Components, Inc dba MedComp
Key facts
| Event ID | 83324 |
|---|---|
| Recall numbers | Z-2215-2019, Z-2216-2019, Z-2217-2019 |
| Recalling firm | Medical Components, Inc dba MedComp |
| Product type | Devices |
| Products | 14F x 20CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061423 Product Usage: An aid for introducing a hemodialysis catheter, 14F x 24CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061424 Product Usage: An aid for introducing a hemodialysis catheter, 14F x 30CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061425 Product Usage: An aid for introducing a hemodialysis catheter |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer. |
| Initiation date | Mar 13, 2019 |
| Report date | Aug 14, 2019 |
| Termination date | Mar 5, 2024 |
| City | Harleysville |
| State | PA |
| Country | United States |
| FEI number | 2518902 |
At a glance
- 1–9 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: