Reported Feb 5, 2014 · Terminated
Port Kit with Access Infusion Set under the following labels
Navilyst Medical, 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: Navilyst Medical, Inc. · 26 Forest St · Marlborough, MA · 01752-3068
Is this the product you have?
Port Kit with Access Infusion Set under the following labels
15 of 15 products
| Model / number | Product as published |
|---|---|
45-014 | 8F/SL/Plastic Port/F, Product Number H965450140 |
45-017 | 8F/SL/Titanium Ports/NF, Product Number H965450170 |
45-020 | 6F/SL/Plastic Port/F, Product Number H965450200 |
45-022 | 8F/SL/Plastic Port/F, Product Number H965450220 |
45-025 | 8F/SL/Titanium Ports/F, Product Number H965450250 |
45-029 | Plastic/6F/non-filled/non-valved, Product Number H965450290 |
45-030 | Plastic/6F/filled/non-valved, Product Number H965450300 |
45-031 | Plastic/8F/non-filled/non-valved, Product Number H965450310 |
45-032 | Plastic/8F/filled/non-valved, Product Number H965450320 |
45-037 | Plastic/6F/non-filled/valved, Product Number H965450370 |
45-038 | Plastic/6F/filled/valved, Product Number H965450380 |
45-039 | Plastic/8F/non-filled/valved, Product Number H965450390 |
45-040 | Plastic/8F/filled/valved, Product Number H965450400 |
45-041 | Titanium/6F/non-filled/valved, Product Number H965450410 |
45-043. | Titanium/8F/non-filled/valved, Product Number H965450430, Product Usage: ***K-Shield Port Access Infusion Set, (affected product) supplied by Kawasumi Laboratories. The K-Shield Port Access Infusion Set with High Pressure Tubing is an intravascular administration set with a non-coring Huber needle that is used to access an implanted medication port for solution infusion. This device is also indicated for injection of contrast media by a power injector only with power injectable implanted port.***NMI Port is indicated for patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal. |
- Lot codes and dates
- Batch/Lot Numbers
468888146888834688884468888546888874668695465406046540604659108466869946540614659109466870046540624659110466870146540634658398466258146649854675021468115646540644654065465839946584004662583 and 4675023
- Batch/Lot Numbers
- Amount recalled
- 920 Total kits
Where it was sold
Why it was recalled
Navilyst Medical has recalled a Port Kit with Access Infusion Set due to a possible breach of sterilization barrier.
This product could cause temporary or reversible health problems — stop using it.
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