FDA Device recall Z-1149-2019
14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422
- FDA Device
- Class II
- terminated
- Published 2019-04-24
On 2019-04-24 the FDA classified a Class II recall of 14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422 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-1149-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-03-13 |
| Published | 2019-04-24 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Medical Components |
| Distribution | CA, FL, GA, IN, KY, LA, MA, MI, MO, MS, NJ, NY, OH, OK, PA, SC, TN, TX, VA, WV |
Product
14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422
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 | MCAL680 MCBA840 MCBH140 MCBK600 MCBY920 MCCH670 MCCR320 MCCV590 MCDG930 MCDK980 MCDR400 MCFB320 MCFG490 MC…MCAL680 MCBA840 MCBH140 MCBK600 MCBY920 MCCH670 MCCR320 MCCV590 MCDG930 MCDK980 MCDR400 MCFB320 MCFG490 MCFR460 MCFT410 MCFY850 MCFZ660 MKAD410 MKAN270 MKAP300 MKAT100 MKAX320 MKBA190 MKBK940 MKBL210 MKBP450 MKBV570 MMAA170 MMAD480 MMAS020 |
|---|
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-1149-2019%22
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