Reported Apr 5, 2017 · Terminated
Regard, Item Number: 880328001, Sterile, HT0759A - Pacemaker Pk - OSU
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 · 65803-6317
Is this the product you have?
- Regard
- Item Number
880328001SterileHT0759A - Pacemaker Pk - OSU
- Lot codes and dates
031483A Exp Date 2017-02-27034832A Exp Date 2017-12-03
- Amount recalled
- 28 kits
This recall covers 135 products
The agency filed one notice per product. You are reading one of them; the other 134 are below.
122 more are in the archive.
Where it was sold
Why it was recalled
Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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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