# FDA recall Z-2216-2019

> **Medical Components, Inc dba MedComp** · Class II · device recall initiated 2019-03-13.

## Product

14F x 24CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061424     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.

## Distribution

US Nationwide Distribution CA FL GA IN KY LA MA MI MO MS NJ NY OH OK PA SC TN TX VA WV.

## Key facts

- **Recall number:** Z-2216-2019
- **Recalling firm:** Medical Components, Inc dba MedComp
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-03-13
- **Report date:** 2019-08-14
- **Termination date:** 2024-03-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Harleysville, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2216-2019

## Citation

> AI Analytics. FDA recall Z-2216-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2216-2019. Source: US FDA. Licensed CC0.

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