# FDA recall Z-0918-2020

> **ROi CPS LLC** · Class II · device recall initiated 2020-01-03.

## Product

Custom procedure packs, containing Clearlink Continu-Flo, labeled as follows:  a) regard LD00200L-VAG DELIVERY MOTHER - JOPLIN, Item Number 830015012  b) regard GS00310C - Max Barrier Central Line Trpl Lumen 16cm, Sulfa-coated catheter, Item Number: 830027  c) regard GS00309B - Max Barrier Central Line Dual Lumen 16cm, Sulfa-coated catheter, Item Number: 830026  d) regard GS00307B - Max Barrier Central Line Trpl Lumen 20cm, Sulfa-coated catheter, Item Number: 830024  e) regard AN00211K - PICC PACK - WASHINGTON, Item Number, 880189011  f) regard GS00311B - Max Barrier Central Line Quad Lumen 20cm, Sulfa-coated catheter, Item Number: 830028  g) regard LD00866B-VAG DELIVERY MOTHER - LEBANON, Item Number 830084  h) regard LD00199NL-C SECTION MOTHER - JOPLIN, Item Number 830014  i)  regard GS0348D - CVC TRIPLE LUMEN 20CM NON SULFA -  , Item Number 830034    Product Usage:    These custom procedural trays contain surgical instruments and accessories intended for use during a surgical procedu

## Reason for recall

ROi CPS, LLC manufactured custom procedure packs using Clearlink Continu-Flo devices which were subsequently recalled by Baxter Healthcare Corporation.

## Distribution

US: AR, OK, MO, KS

## Key facts

- **Recall number:** Z-0918-2020
- **Recalling firm:** ROi CPS LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-01-03
- **Report date:** 2020-02-05
- **Termination date:** 2020-11-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Republic, MO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0918-2020

## Citation

> AI Analytics. FDA recall Z-0918-2020. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0918-2020. Source: US FDA. Licensed CC0.

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