PlainRecalls
FDA Devices Verify with FDA Devices → Critical Class I Ongoing

MEDLINE Kits, trays, and packs labeled as follows: a) ARTERIAL LINE PACK, REF DYNJ65208A; b) CANCER SERVICE PORT KIT, REF DT22710; c) CAP CHANGE KIT, REF DYNDC2002A; d) CAP CHANGE KIT, REF DYNDC2723A; e) CAP CHANGE KIT, REF DYNDC2723B; f) CENTRAL LINE INSERTION PACK, REF CVI4805; g) CENTRAL LINE TRAY, REF CVI4705; h) CNTRL LINE DRSG CHG OUTPATIENT, REF DYNDC2721A; i) CNTRL LINE DRSG CHG OUTPATIENT, REF DYNDC2721B; j) CVC INSERTION PACK, REF CVI4720; k) CVC INSERTION PACK,

Reported: March 6, 2024 Initiated: November 15, 2023 #Z-1097-2024

MEDLINE INDUSTRIES, LP - Northfield issued this FDA Devices recall on March 6, 2024. Classified as Critical severity (Class I). The recall was issued because: Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (…. 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-1097-2024) was formally reported on March 6, 2024, with the manufacturer initiating the action on November 15, 2023. It is classified under Critical severity (Class I), with a current status of Ongoing. MEDLINE INDUSTRIES, LP - Northfield is listed as the recalling firm, operating out of Northfield, IL. The number of affected units is not disclosed in the agency filing, which is common for drug and food recalls where lot-level tracking supersedes unit counts.

The documented reason for this recall is: Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Fl… Distribution data in the federal record shows the product reached: Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama. 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 2 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

Severity1Class I (Critical)Class II (Moderate)Class III (Low)
Recall Distribution by Severity Class

Severity

Critical

Units Affected

Unknown

Related Recalls

6

6 from same agency

Product Description

MEDLINE Kits, trays, and packs labeled as follows: a) ARTERIAL LINE PACK, REF DYNJ65208A; b) CANCER SERVICE PORT KIT, REF DT22710; c) CAP CHANGE KIT, REF DYNDC2002A; d) CAP CHANGE KIT, REF DYNDC2723A; e) CAP CHANGE KIT, REF DYNDC2723B; f) CENTRAL LINE INSERTION PACK, REF CVI4805; g) CENTRAL LINE TRAY, REF CVI4705; h) CNTRL LINE DRSG CHG OUTPATIENT, REF DYNDC2721A; i) CNTRL LINE DRSG CHG OUTPATIENT, REF DYNDC2721B; j) CVC INSERTION PACK, REF CVI4720; k) CVC INSERTION PACK, REF CVI4720A; l) CVC INSERTION PACK, REF CVI4720AH; m) DERM SURG CUSTOM PACK, REF DYNDA1584C; n) ER CENTRAL LINE KIT, REF P155508D; o) FISTULA GRAFT KIT, REF DT20345A; p) IMPLANTED PORT ACCESS, REF DYNDC2765B; q) IVAD KIT, REF DYNDC2004B; r) KIT LINE INSERTION, REF CVI4730H; s) KIT LINE INSERTION, REF CVI4730; t) LINE CHANGE KIT, REF DYNDC2927A; u) MAX BARRIER PACK, REF DYNJ50717; v) MEDIPORT W/CHG, REF DYNDC2219B; w) MEDIPORT W/CHG, REF DYNDC2219BH; x) NICU PICC INSERTION KIT, REF CVI4395B; y) PACK,CENTRAL LINE, REF DYNJ906907B; z) PEDI CENTRAL LINE AND PORT ACC, REF DT19740A; aa) PEDS INFANT LUMBAR PUNCTURE, REF DYNDH1636; bb) PEDS/ NICU LINE KIT, REF MNS13555; cc) PICC LINE PACK, REF DYNJ64249A; dd) PICC LINE TRAY, REF DYNDC2170; ee) PORT ACCESS KIT, REF DYNDC3251; ff) PORT ACCESS KIT, REF DYNDC3251H; gg) PORT ACCESS KIT, REF DYNDC3252; hh) PORT ACCESS SUPPLIES, REF DYNDA2142B; ii) PORT ACCESS TRAY, REF DYNDC2449B; jj) PORT ACCESS TRAY, REF DYNDC3066; kk) PORT ACCESS TRAY, REF DYNDC3103; ll) PORT ACCESS/LAB KIT, REF DYNDC3129A; mm) PORT ACCESS/LAB KIT, REF DYNDC3129AH; nn) PORT FULL ACCESS TRAY, REF DT19330B; oo) PORT KIT, REF DT22785; pp) PORT KIT W/ HUBER NEEDLE, REF DT22780; qq) PORT-A-CATH ACCESS KIT, REF DYNDC1994C; rr) PORT-A-CATH ACCESS KIT, REF DYNDC1994D; ss) PORT-A-CATH ACCESS KIT, REF DYNDC1994DH; tt) SUBCLAVIAN PORT ACCESS, REF DYNDC2555C; uu) USG PIV INSERTION KIT, REF DYNDV2480; vv) USG PIV INSERTION KIT, REF DYNDV2480H; ww) VAD DRESSING CHANGE TRAY, REF DYNDC2078; xx) VAD DRESSING CHANGE TRAY, REF DYNDC2078H; yy) VAD DRESSING CHANGE TRAY, REF DYNDC2657A; zz) VAD KIT WITHOUT VALVES, REF DYNDC3179; aaa) VEIN CLOSURE PACK, REF DYNJ69976

Reason for Recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Details

Distribution
Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
Location
Northfield, IL

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Critical (Class I)
Status Ongoing
Recall number Z-1097-2024
Date reported March 6, 2024
Date initiated November 15, 2023
Recalling firm MEDLINE INDUSTRIES, LP - Northfield
Units affected Not disclosed
Distribution Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

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

Frequently Asked Questions

What product was recalled? ▼
MEDLINE Kits, trays, and packs labeled as follows: a) ARTERIAL LINE PACK, REF DYNJ65208A; b) CANCER SERVICE PORT KIT, REF DT22710; c) CAP CHANGE KIT, REF DYNDC2002A; d) CAP CHANGE KIT, REF DYNDC2723A; e) CAP CHANGE KIT, REF DYNDC2723B; f) CENTRAL LINE INSERTION PACK, REF CVI4805; g) CENTRAL LINE TRAY, REF CVI4705; h) CNTRL LINE DRSG CHG OUTPATIENT, REF DYNDC2721A; i) CNTRL LINE DRSG CHG OUTPATIENT, REF DYNDC2721B; j) CVC INSERTION PACK, REF CVI4720; k) CVC INSERTION PACK, REF CVI4720A; l) CVC INSERTION PACK, REF CVI4720AH; m) DERM SURG CUSTOM PACK, REF DYNDA1584C; n) ER CENTRAL LINE KIT, REF P155508D; o) FISTULA GRAFT KIT, REF DT20345A; p) IMPLANTED PORT ACCESS, REF DYNDC2765B; q) IVAD KIT, REF DYNDC2004B; r) KIT LINE INSERTION, REF CVI4730H; s) KIT LINE INSERTION, REF CVI4730; t) LINE CHANGE KIT, REF DYNDC2927A; u) MAX BARRIER PACK, REF DYNJ50717; v) MEDIPORT W/CHG, REF DYNDC2219B; w) MEDIPORT W/CHG, REF DYNDC2219BH; x) NICU PICC INSERTION KIT, REF CVI4395B; y) PACK,CENTRAL LINE, REF DYNJ906907B; z) PEDI CENTRAL LINE AND PORT ACC, REF DT19740A; aa) PEDS INFANT LUMBAR PUNCTURE, REF DYNDH1636; bb) PEDS/ NICU LINE KIT, REF MNS13555; cc) PICC LINE PACK, REF DYNJ64249A; dd) PICC LINE TRAY, REF DYNDC2170; ee) PORT ACCESS KIT, REF DYNDC3251; ff) PORT ACCESS KIT, REF DYNDC3251H; gg) PORT ACCESS KIT, REF DYNDC3252; hh) PORT ACCESS SUPPLIES, REF DYNDA2142B; ii) PORT ACCESS TRAY, REF DYNDC2449B; jj) PORT ACCESS TRAY, REF DYNDC3066; kk) PORT ACCESS TRAY, REF DYNDC3103; ll) PORT ACCESS/LAB KIT, REF DYNDC3129A; mm) PORT ACCESS/LAB KIT, REF DYNDC3129AH; nn) PORT FULL ACCESS TRAY, REF DT19330B; oo) PORT KIT, REF DT22785; pp) PORT KIT W/ HUBER NEEDLE, REF DT22780; qq) PORT-A-CATH ACCESS KIT, REF DYNDC1994C; rr) PORT-A-CATH ACCESS KIT, REF DYNDC1994D; ss) PORT-A-CATH ACCESS KIT, REF DYNDC1994DH; tt) SUBCLAVIAN PORT ACCESS, REF DYNDC2555C; uu) USG PIV INSERTION KIT, REF DYNDV2480; vv) USG PIV INSERTION KIT, REF DYNDV2480H; ww) VAD DRESSING CHANGE TRAY, REF DYNDC2078; xx) VAD DRESSING CHANGE TRAY, REF DYNDC2078H; yy) VAD DRESSING CHANGE TRAY, REF DYNDC2657A; zz) VAD KIT WITHOUT VALVES, REF DYNDC3179; aaa) VEIN CLOSURE PACK, REF DYNJ69976. Recalled by MEDLINE INDUSTRIES, LP - Northfield.
Why was this product recalled? ▼
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 6, 2024. Severity: Critical. Recall number: Z-1097-2024.
Where was the recalled product distributed? ▼
Distribution: Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1097-2024) 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 critical severity, meaning the product carries a reasonable probability of serious adverse health consequences or death. 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

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