FDA Devices Verify with FDA Devices → Moderate Class II Terminated

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 H965

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on February 5, 2014. Severity: Moderate. Recall number: Z-0826-2014.

Q: Where was the recalled product distributed?

Distribution: 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..

Q: How do I check if my product is affected by a recall?

Check the product description and recall number (Z-0826-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Reviewed byPlainRecalls Editorial, Product Recalls Editorial Team · June 7, 2026

Reported: February 5, 2014 Initiated: November 25, 2013 #Z-0826-2014 920 Total kits units

Navilyst Medical, Inc. issued this FDA Devices recall on February 5, 2014. Classified as Moderate severity (Class II). Approximately 920 Total kits units are affected. The recall was issued because: Navilyst Medical has recalled a Port Kit with Access Infusion Set due to a possible breach of sterilization barrier.. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.

Recall Insight

This FDA Devices action (record #Z-0826-2014) was formally reported on February 5, 2014, with the manufacturer initiating the action on November 25, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Navilyst Medical, Inc. is listed as the recalling firm, operating out of Marlborough, MA. Federal records indicate 920 Total kits units are affected.

The documented reason for this recall is: Navilyst Medical has recalled a Port Kit with Access Infusion Set due to a possible breach of sterilization barrier. Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 12 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.

Recall Distribution by Severity Class

Severity

Moderate

Units Affected

920 Total kits

Related Recalls

6 from same agency

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.

Reason for Recall

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

Details

Recalling Firm: Navilyst Medical, Inc.
Units Affected: 920 Total kits
Distribution: 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.
Location: Marlborough, MA

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-0826-2014
Date reported	February 5, 2014
Date initiated	November 25, 2013
Recalling firm	Navilyst Medical, Inc.
Units affected	920 Total kits
Distribution	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.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

920 Total kits units affected — limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) —

Large-scale (100K – 1M units) —

Massive (≥1M units) —

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

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

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on February 5, 2014. Severity: Moderate. Recall number: Z-0826-2014.

Where was the recalled product distributed? ▼

Distribution: 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..

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (Z-0826-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Recall Guides

Learn how the US recall system works and how to protect yourself and your household.

How the US Recall System Works

The three federal agencies, how recalls are initiated, and what happens next.

Understanding Recall Severity Classes

What Class I, II, and III mean and which recalls demand immediate action.

What to Do When a Product Is Recalled

Verify, claim your remedy, report injuries, and navigate the process.

How to Check If Your Products Are Recalled

Step-by-step guide to checking food, products, medications, and vehicles.

Recalled Products in Your Home

A room-by-room household audit guide for active recalls.

Most Recalled Product Categories

Rankings of highest-recall categories from FDA, CPSC, and NHTSA.

Recall Context

Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as moderate severity, indicating the product may cause temporary or medically reversible health consequences. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.

Related Safety Data

Explore related product safety and public health data from federal sources.

Food Safety Inspections

FDA and state food facility inspection results — violations, enforcement actions, and compliance history for food manufacturers and processors.

PlainFoodSafe →

Ingredient Safety Data

FDA food additive and ingredient safety database — regulatory status, usage limits, and safety assessments for thousands of ingredients.

PlainIngredients →

Nutrition Data

USDA nutrition facts for 2M+ food items — calories, macros, vitamins, and ingredient analysis to verify what you consume.

GetFoodFacts →

Drug Safety Information

FDA drug data for 680+ medications — interactions, alternatives, side effects, and safety information for recalled and active drugs.

PlainMeds →

Product Injury Data

CPSC emergency room injury data for 838 product categories — 7.3M NEISS records tracking real-world consumer product injuries.

PlainSafety →

Recall Checker

Search our database of 83K+ recalls by product name, brand, or recall number across all agencies.

Check Now →

Recall Radar

Live feed of the latest recalls across FDA, CPSC, NHTSA, and USDA — filter by agency and severity.

View Radar →

Nearby Recalls in This Category

Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.

FDA Devices Moderate

Endo-Model Replacement Plateau; Item Number: 15-0027/11;

Waldemar Link GmbH & Co. KG (Mfg Site) · 2026-03-18

FDA Devices Low

Penner Pacific Bathing Spa, Model Numbers 360020-1P

Penner Patient Care, Inc. · 2026-03-18

FDA Devices Moderate

GEM Premier 5000 PAK, Part No. 00055360004.

Instrumentation Laboratory · 2026-03-18

FDA Devices Moderate

CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281

Beckman Coulter Mishima K.K. · 2026-03-18

FDA Devices Critical

Owner's Booklets and Instructions for Use that are used with the following blood glucose measurement devices. Descript…

Trividia Health, Inc. · 2026-03-18

Compare this recall with Endo-Model Replacement Plateau; Item Number: 15-0027/11; →

Data Sources

Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.

Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

Read our methodology — how this data is sourced, computed, and verified.

All federal data sources used on this page

U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov

Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Accessed 2026-06-07 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).