14F x 30CM SLX Double Lumen Full Tray Hemodialysis catheter insertion… — Class II medical device recall Z-2217-2019
Terminated recall by Medical Components, Inc dba MedComp, reported 2019-08-14, distributed nationwide. Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F
| Recall number | Z-2217-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medical Components, Inc dba MedComp, Harleysville, PA, United States |
| Recall initiated | 2019-03-13 |
| Classified | 2019-08-07 |
| Reported by FDA | 2019-08-14 |
| Terminated | 2024-03-05 |
| Distributed | Nationwide (US) |
| Quantity | 6,830 |
| Reason classes | labeling |
| Model numbers | MC061425 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2217-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.