Reported Dec 28, 2016 · Terminated
Best Practices kits containing certain production lots of Clearify Visualization System Item Code: 21-345 Intended to…
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?
- Best Practices kits containing certain production lots of
- 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
- Kit Parent Codes
00Z222400Z223200Z229800Z236300Z236400Z236500Z236600Z242100Z242500Z243000Z243100Z246000Z249300Z253400Z2535000Z254400Z5000B00Z5001BGYNKIT2
- Kit Parent Codes
- Amount recalled
- 230 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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