Reported Jun 22, 2016 · Terminated
Vaxcel PICC with PASV MST-60 Kit under the following labels
Navilyst Medical, Inc., an AngioDyamics Company
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: Navilyst Medical, Inc., an AngioDyamics Company · 10 Glens Falls Tech Park · Glens Falls, NY · 12801-3864
Is this the product you have?
Vaxcel PICC with PASV MST-60 Kit under the following labels
3 of 3 products
| # | Product as published |
|---|---|
| 1 | 3F, UPN H965454360, Rx ONLY |
| 2 | 4F, UPN M001454590, Rx ONLY |
| 3 | 5F, UPN's M001454640, M001454740 & M001454790, Rx ONLY The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. This product is intended for central venous access in adults, children and infants who require intravenous (IV) therapy. |
- Lot codes and dates
3 of 3 products
Products covered by this recall # Product as published 1 4724945, 4731137, 4738296, 4895232, 4912062, 4933353 2 4731139, 4738302, 4748674, 4776152 3 4721239, 4784467, 4810672, 4812161, 4821239, 4821511, 4824106, 4830612, 4832722, 4836599, 4724949, 4724950, 4738298, 4738299, 4773297, 4773298, 4786764, 4823438, 4829478, 4832723,4845209, 4724926 & 4734253 with Use By Date Range 2016-03-31 to 2017-09-30. - Amount recalled
- 5,566 units
This recall covers 23 products
The agency filed one notice per product. You are reading one of them; the other 22 are below.
10 more are in the archive.
Where it was sold
Why it was recalled
PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter.
This product could cause temporary or reversible health problems — stop using it.
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