Z-0918-2020Class II

Custom procedure packs, containing Clearlink Continu-Flo, labeled as follows: a) regard LD00200L-VAG DELIVERY...

Name: Z-0918-2020 Custom procedure packs, containing Clearlink Continu-Flo, labeled as follows: a) regard LD00200L-VAG DELIVERY...
Creator: ROi CPS LLC
Published: 2020-01-03
License: https://open.fda.gov/license/

ROi CPS LLC / initiated 2020-01-03 / Terminated / root cause: manufacturing process

FDA source

ROi CPS LLC began a recall of Custom procedure packs, containing Clearlink Continu-Flo, labeled as follows: a) regard LD00200L-VAG DELIVERY MOTHER - JOPLIN, Item Number 830015012 b) regard... on 2020-01-03. FDA classified it as Class II and gives the reason as "ROi CPS, LLC manufactured custom procedure packs using Clearlink Continu-Flo devices which were subsequently recalled by Baxter Healthcare Corporation". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0918-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-03
Posted: 2020-01-30
Terminated: 2020-11-20
Recalling firm: ROi CPS LLC
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 procedure.
Product code: LRO General Surgery Tray
Reason for recall: ROi CPS, LLC manufactured custom procedure packs using Clearlink Continu-Flo devices which were subsequently recalled by Baxter Healthcare Corporation.
Root cause tag: manufacturing process
FDA root cause: Other
Action: The firm notified its direct consignee by letter disseminated by email on 01/03/2020. The direct consignee in turn notified the end user by email. The notice requested that the user follow the IFU and ensure a full and secure friction fit between the Continu-Flo Luer and the ONE-LINK connector.
Quantity in commerce: 412 packs
Distribution: US: AR, OK, MO, KS
Product codes and lots: a) Item Number 830015012 Lot Numbers: 72700L, 74508L b) Item Number: 830027 Lot Numbers: 72702C, 74406C c) Item Number: 830026 Lot Numbers: 72897B d) Item Number: 830024 Lot Numbers: 73325B, 74403B e) Item Number, 880189011 Lot Numbers: 73173K, 74855K f) Item Number: 830028 Lot Numbers: 73666B g) Item Number 830084 Lot Numbers: 74354B h) Item Number 830014 Lot Numbers: 74373N i) Item Number 830034 Lot Numbers: 68336D

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0918-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0918-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-30

Product code LRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)