Reported Aug 14, 2019 · Ongoing

Regard ¿ custom surgical pack labeled as "LAP - FLOL LADY OF ANGELS" including recalled Stryker part numbers 0620 040…

ROi Consolidated Service Center (CSC)

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: ROi Consolidated Service Center (CSC) · 2909 N Neergard Ave · Springfield, MO · 65803-6317

Is this the product you have?

3 of 3 products

Products covered by this recall
#Product as published
1Pneumosure High Flow II Tubeset, 0620 040 690
2Pneumosure Heated Tubeset with RTP and 0620 040 680
3Pneumosure High Flow Tubeset with RTP.
Lot codes and dates
  • Item Number (Lot Number
  • Expiration Date)
    • 800096004 (044343D
    • 43590)
    • 800096004 (048023D
    • 43722)
    • 800096004 (049262D
    • 43757)
    • 800096004 (052020D
    • 43856)
    • 800096004 (054482D
    • 43948)
    • 800096004 (057619D
    • 44035)
    • 800096005 (059908E
    • 44080)
    • 800096005 (062938E
    • 44151)
    • 800096005 (65606E
    • 44232)
Amount recalled
261 packs

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:53 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.