Reported Dec 28, 2016 · Terminated
Covidien Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and…
Medtronic
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: Medtronic · 60 Middletown Ave · North Haven, CT · 06473-3908
Is this the product you have?
- Covidien
- Clearify Visualization System Item Code21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens
- Lot codes and dates
- Lots beginning with
P4JP4KP4LP4MP5AP5BP5CP5DP5EP5FP5GP5HP5JP5KP5LP5MP6AP6BP6CP6D and lots P6E0016GXP6E0049GXP6E0050GXP6E0051GXP6E0052GXP6E0163GXP6E0164GXP6E0212GX
- Lots beginning with
- Amount recalled
- 1,293,169 systems
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
- Nationwide
Why it was recalled
Product sterility is compromised due to breach of the sterile barrier
This product could cause temporary or reversible health problems — stop using it.
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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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