Reported May 29, 2019 · Terminated
MoniTorr 10100 10-100 CSF Drainage System w/Patient Line One Way Valve MoniTorr 10102 10-102 CSF Drainage System…
Integra LifeSciences Corp.
High riskUsing this product could cause serious injury, illness or death — stop using it now.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: Integra LifeSciences Corp. · 311 Enterprise Dr · Plainsboro, NJ · 08536-3344
Is this the product you have?
11 of 11 products
| Model / number | Product as published |
|---|---|
10100 | MoniTorr |
10102 | Drainage System w/Patient Line One Way Valve MoniTorr |
10110 | Drainage System w/Patient Line One Way Valve w MoniTorr |
10140 | Drainage System used with Pole Mount System MoniTorr |
10150 | Drainage System w/Vinyl Measuring Strip MoniTorr |
10110A | Drainage System Simple Bag and Line MoniTorr |
SP0017 | Drainage System w/o Manifold Stopcock MoniTorr |
SP0042 | EVD 10-110 w/o Y Site Latex Free Sites MoniTorr |
SP0090 | EVD 10-100 w/o Y Site MoniTorr |
SP0164 | EVD 10-110 w/o Y Site MoniTorr |
SP0236 | EVD 10-140 w/Y Site & Stopcock Reverse MoniTorr |
- Lot codes and dates
- All lots
- Amount recalled
- 42102 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and MoniTorr Panel Mount stopcock.
Using this product could cause serious injury, illness or death — stop using it now.
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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