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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84643

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
January 03, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
ROi CPS LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-0918-2020
Recall number
Z-0918-2020
Initiated
January 03, 2020
Classification
Class II
Status
Terminated
Recalling firm
ROi CPS LLC
Quantity
412 packs

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
ROi CPS, LLC manufactured custom procedure packs using Clearlink Continu-Flo devices which were subsequently recalled by Baxter Healthcare Corporation.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

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Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

US: AR, OK, MO, KS