Medical convenience trays and kits, labeled as: Medical Action Industries, Inc.: ***CVC*** Clear Sequence…
Medical device recall Z-0779-2020. Published in FDA’s Enforcement Report on Jan 15, 2020.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jan 15, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 21 states named in where it went
- 9924 cases how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
The kits contain a bottle of saline solution which may exceed the USP specified pH requirements of 4.5-7.0.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
9924 cases, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
***CVC*** Clear Sequence Change Kit, REF 77070B Lot Numbers: 0000250140 0000250814 0000251345 0000252860 0000253786 0000254661 0000255539 0000256372 0000256478 0000256896 0000257916 0000259710 0000260807 0000261950 0000262411 0000262853…
Every code shown here, 1,991 characters
***CVC*** Clear Sequence Change Kit, REF 77070B Lot Numbers: 0000250140 0000250814 0000251345 0000252860 0000253786 0000254661 0000255539 0000256372 0000256478 0000256896 0000257916 0000259710 0000260807 0000261950 0000262411 0000262853 0000263255 0000248930 0000248004 0000245391 ***DIALYSIS*** Clear Sequence Change Kit, REF 77068B Lot Numbers: 0000255949 0000256795 0000258076 0000260410 0000261183 0000262656 0000257187 ***PEDS CVC*** Clear Sequence Change Kit, REF 77190B Lot Numbers: 0000261186 0000261949 0000263402 0000245684 ***PICC*** Clear Sequence Change Kit, REF 77069B Lot Numbers: 0000250126 0000250752 0000251646 0000252449 0000255455 0000256371 0000256796 0000256897 0000257625 0000258163 0000260908 0000262404 0000262852 0000249190 0000248773 Adult Central Line Dressing Change Kit, REF 74636C Lot Numbers: 0000250172 0000251684 0000251775 0000252730 0000255062 0000255669 0000256289 0000257970 0000259210 0000259867 0000260734 0000263279 0000264415 0000248260 Central Line Dressing Kit, VCU, REF 57647B Lot Numbers: 0000249224 0000248261 Central Line Removal Kit, REF 78631B Lot Numbers: 0000258405 0000264395 Chest Tube Cleaning Kit, REF 73000 Lot Numbers: 0000254875 0000256642 0000257028 0000261394 0000248107 0000247565 0000246033 0000244487 CVC Dressing Change Kit, REF 80643D Lot Numbers: 0000263867 Dressing Change Kit, REF 71538 Lot Numbers: 256205 0000256888 ED Suture Set, REF 59299C Lot Numbers: 0000250820 0000252658 0000254734 0000255276 0000257072 0000260553 0000262731 Laceration Kit, REF 59806B Lot Numbers: 0000250817 0000252940 0000253601 Laceration Tray, REF 56957 Lot Numbers: 0000255242 0000257303 0000258844 0000260451 0000263359 Laceration Tray, REF 57888B Lot Numbers: 0000255947 0000257545 0000257931 0000259064 0000260150 0000261007 0000262982 0000263363 Laceration Tray, REF 59387 Lot Numbers: 0000248176 0000247839 Laceration Tray, REF 59387B Lot Numbers: 0000255606 0000256080 0000256505 0000259051 0000259659 0000260338 0000261192 0000262714…
FDA’s list runs to 3,793 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
MA, RI, PA, MD, VA, NC, SC, GA, FL, KY, OH, IN, MI, IL, MO, NE, LA, TX, AZ, CA, WA
The states and territories these words name
21 states and territories.
Every one of them
- Arizona
- California
- Florida
- Georgia
- Illinois
- Indiana
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Missouri
- North Carolina
- Nebraska
- Ohio
- Pennsylvania
- Rhode Island
- South Carolina
- Texas
- Virginia
- Washington
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Dec 2, 2019.
- FDA classified it on Jan 6, 2020.
- FDA’s Enforcement Report published it on Jan 15, 2020.
- FDA terminated it on Jan 24, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Medical Action Industries, Inc. 306, of Arden, NC.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 3,793 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.