Reported Jun 27, 2018 · Terminated
Drainer(R) Centesis Catheters
Vascular Solutions, Inc.
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: Vascular Solutions, Inc. · 6464 Sycamore Ct N · Maple Grove, MN · 55369-6032
Is this the product you have?
Drainer(R) Centesis Catheters
3 of 3 products
| Model / number | Product as published |
|---|---|
8810 | 5F x 9cm (b) |
8811 | 6F x 9cm (c) |
8812 | 5F x 15cm Product The Drainer centesis catheter is intended for use in percutaneous fluid aspirations and small volume drainage procedures. |
- Lot codes and dates
a) REF 88105F x 9cm
- Lot Numbers
1803712818057123 (b) REF 88116F x 9cm
- Lot Numbers
1802606218026063 (c) REF 88125F x 15cm
- Lot Number18050076
- Amount recalled
- 276 units
Where it was sold
- Nationwide
Why it was recalled
The supplier of Drainer(R) centesis catheters notified Vascular Solutions, Inc. that there is a potential for certain production lots to contain unsafe levels of bacterial endotoxins.
This product could cause temporary or reversible health problems — stop using it.
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