FDA Device recall Z-2217-2019
14F x 30CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061425 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 30CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061425 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-2217-2019 |
| 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 30CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061425 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 | MCAM240 MCBL480 MCBS870 MCCF480 MCCJ320 MCCW690 MCCZ500 MCFG830 MCFR160 MCFS760 MCFZ360 MKAJ330 MKAR130 MKBL500 MKBX060 MMAB730 |
|---|
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-2217-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.