FDA Device recall Z-2215-2019
14F x 20CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061423 Product Usage: An aid for introducing a hemod…
- FDA Device
- Class II
- terminated
- Published 2019-08-14
On 2019-08-14 the FDA classified a Class II recall of 14F x 20CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061423 Product Usage: An aid for introducing a hemod… by Medical Components, citing tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2215-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-03-13 |
| Published | 2019-08-14 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Medical Components |
| Distribution | US |
Product
14F x 20CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061423 Product Usage: An aid for introducing a hemodialysis catheter
Reason
Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.
Identifiers
| code_info | MCAK580 MCAS990 MCAY850 MCBA850 MCBH150 MCBN670 MCBY930 MCCC770 MCCK640 MCCN740 MCCR330 MCCW790 MCDC600 MCDK990 MCDR410…MCAK580 MCAS990 MCAY850 MCBA850 MCBH150 MCBN670 MCBY930 MCCC770 MCCK640 MCCN740 MCCR330 MCCW790 MCDC600 MCDK990 MCDR410 MCFB340 MCFG840 MCFL120 MCFP220 MCFT420 MCFZ280 MKAF340 MKAG480 MKAN280 MKAT110 MKAX330 MKBA730 MKBH920 MKBN710 MKBX790 MMAB370 MMAD450 MMAQ940 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2215-2019%22
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