Navilyst Medical, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0826-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Port Kit with Access Infusion Set under the following labels: 1) 8F/SL/Plastic Port/F, Product Number H965450140, Catalog Number 45-014; 2) 8F/SL/Titanium Ports/NF, Product Number H965450170, Catalog Number 45-017; 3) 6F/SL/Plastic Port/F, Product Number H965450200, Catalog Number 45-020; 4) 8F/SL/Plastic Port/F, Product Number H965450220, Catalog Number 45-022; 5) 8F/SL/Titanium Ports/F, Product Number H965450250, Catalog Number 45-025; 6) Plastic/6F/non-filled/non-valved, Product Number H965450290, Catalog Number 45-029; 7) Plastic/6F/filled/non-valved, Product Number H965450300, Catalog Number 45-030; 8) Plastic/8F/non-filled/non-valved, Product Number H965450310, Catalog Number 45-031; 9) Plastic/8F/filled/non-valved, Product Number H965450320, Catalog Number 45-032; 10) Plastic/6F/non-filled/valved, Product Number H965450370, Catalog Number 45-037; 11) Plastic/6F/filled/valved, Product Number H965450380, Catalog Number 45-038; 12) Plastic/8F/non-filled/valved, Product Number H965450390, Catalog Number 45-039; 13) Plastic/8F/filled/valved, Product Number H965450400, Catalog Number 45-040; 14) Titanium/6F/non-filled/valved, Product Number H965450410, Catalog Number 45-041; 15) Titanium/8F/non-filled/valved, Product Number H965450430, Catalog Number 45-043. 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.

Product Classification:

Class II

Date Initiated: November 25, 2013

Date Posted: February 5, 2014

Recall Number: Z-0826-2014

Event ID: 67122

Reason for Recall:

Navilyst Medical has recalled a Port Kit with Access Infusion Set due to a possible breach of sterilization barrier.

Status: Terminated

Product Quantity: 920 Total kits

Code Information:

Batch/Lot Numbers: 4688881, 4688883, 4688884, 4688885, 4688887, 4668695, 4654060, 4654060, 4659108, 4668699, 4654061, 4659109, 4668700, 4654062, 4659110, 4668701, 4654063, 4658398, 4662581, 4664985, 4675021, 4681156, 4654064, 4654065, 4658399, 4658400, 4662583 and 4675023

Distribution Pattern:

US Nationwide Distribution in the states of CA, CT, DC, MA, NJ, NY, PA, MD, VA, WV, NC, GA, FL, TN, OH, MN, MT, IL, MO, NE, OK, TX, NM, and WA.

Voluntary or Mandated:

Voluntary: Firm initiated