Severity
Moderate
Medical Action Industries, Inc. 306 issued this FDA Devices recall on January 15, 2020. Classified as Moderate severity (Class II). Approximately 9924 cases units are affected. The recall was issued because: The kits contain a bottle of saline solution which may exceed the USP specified pH requirements of 4.5-7.0.. 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.
This FDA Devices action (record #Z-0779-2020) was formally reported on January 15, 2020, with the manufacturer initiating the action on December 2, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Medical Action Industries, Inc. 306 is listed as the recalling firm, operating out of Arden, NC. Federal records indicate 9924 cases units are affected.
The documented reason for this recall is: The kits contain a bottle of saline solution which may exceed the USP specified pH requirements of 4.5-7.0. Distribution data in the federal record shows the product reached: MA, RI, PA, MD, VA, NC, SC, GA, FL, KY, OH, IN, MI, IL, MO, NE, LA, TX, AZ, CA, 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 6 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.
Severity
Moderate
Units Affected
9924 cases
Related Recalls
6
6 from same agency
Medical convenience trays and kits, labeled as: Medical Action Industries, Inc.: ***CVC*** Clear Sequence Change Kit, REF 77070B ***DIALYSIS*** Clear Sequence Change Kit, REF 77068B ***PEDS CVC*** Clear Sequence Change Kit, REF 77190B ***PICC*** Clear Sequence Change Kit, REF 77069B Adult Central Line Dressing Change Kit, REF 74636C Central Line Dressing Kit, VCU, REF 57647B Central Line Removal Kit, REF 78631B Chest Tube Cleaning Kit, REF 73000 CVC Dressing Change Kit, REF 80643D Dressing Change Kit, REF 71538 ED Suture Set, REF 59299C Laceration Kit, REF 59806B Laceration Tray, REF 56957 Laceration Tray, REF 57888B Laceration Tray, REF 59387 Laceration Tray, REF 59387B Laceration Tray, REF 69477B Laceration Tray, REF 71582 LACERATION/SUTURE REMOVAL, REF 72347 LACERATION/SUTURE REMOVAL, REF 72347B Pediatric Central Line Dressing Kit, REF 74635C PICC Central Line Dressing Kit VCU, REF 59589C PICC/CVC/Central /Dialysis Clear Sequence Dressing Kit, REF 78197 Suture Kit, REF 59836 Trach Care Kit, Kit de Traqueostomia, REF LH_68162B Trach Care Tray, REF 56791B Trach Care Tray, REF 75378 Tracheostomy Care Tray, REF 4129 Tracheostomy Tray, REF 80209 Wound Care Kit, REF 68330 Wound Care Tray, REF 68358 MEDICHOICE: Tracheostomy Kit, Reorder: TRAC1002 THERAPY SUPPLY HOUSE: VAD DRESSING CHANGE KIT, Reorder # 76512B
The kits contain a bottle of saline solution which may exceed the USP specified pH requirements of 4.5-7.0.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0779-2020 |
| Date reported | January 15, 2020 |
| Date initiated | December 2, 2019 |
| Recalling firm | Medical Action Industries, Inc. 306 |
| Units affected | 9924 cases |
| Distribution | MA, RI, PA, MD, VA, NC, SC, GA, FL, KY, OH, IN, MI, IL, MO, NE, LA, TX, AZ, CA, WA |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
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.
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.
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 →
Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.
Waldemar Link GmbH & Co. KG (Mfg Site) · 2026-03-18
Penner Patient Care, Inc. · 2026-03-18
Instrumentation Laboratory · 2026-03-18
Beckman Coulter Mishima K.K. · 2026-03-18
Trividia Health, Inc. · 2026-03-18
Compare this recall with Endo-Model Replacement Plateau; Item Number: 15-0027/11; →
Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
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.
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).