Reported Sep 30, 2015 · Terminated
Regard Custom Surgical Pack, Item Number: 800208002; Sterile, CV0361B - CABG A&B. Used in cardiovascular surgical…
Resource Optimization & Innovation LLC
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: Resource Optimization & Innovation Llc · 2909 N Neergard Ave · Springfield, MO · 65803
Is this the product you have?
- Regard Custom Surgical Pack
- Item Number800208002; Sterile, CV0361B - CABG A&B. Used in cardiovascular surgical procedures
- Lot codes and dates
- 025072B
- Amount recalled
- 67 kits
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
Surgical kits contain a surgical scrub product which may be chemically contaminated and lack sterility assurance.
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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