Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0918-2020 — 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 L

U.S. FDA — Device Enforcement · United States · 2020-01-03 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0918-2020
Date of alert: 2020-01-03
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: ROi CPS LLC
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 830015012

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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