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

Recall Z-2220-2019 — Regard ¿ custom surgical pack labeled as "LAP - FLOL LADY OF ANGELS" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II Tubeset, 0620 040 690 Pneumosure Heated Tubeset with RTP and 0620 040 680 Pneumosure High Flow Tubeset with RTP.

U.S. FDA — Device Enforcement · United States · 2019-03-21 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2220-2019
Date of alert
2019-03-21
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
ROi Consolidated Service Center (CSC)
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
800096004
Reported risk: Resource Optimization & Innovation (ROi) has received a recall notice from Stryker regarding tube sets potentially detaching from the cassette, which can lead to leaking gas or a hissing sound.
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.