Hearth Record

Centurion- Dressing Change Kits DYNDC1182B PICC INSERTION TRAY DYNDC1251D CENTRAL LINE TRAY DYNDC1251D…

Medical device recall Z-1049-2020. Published in FDA’s Enforcement Report on Feb 12, 2020.

FDA’s own record, on accessdata.fda.gov

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 Feb 12, 2020. Copied from openFDA on Oct 20, 2026.

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.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

What’s wrong with it?

Incomplete seals on the sterile package may compromise the sterility

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Which ones are recalled?

Centurion- Dressing Change Kits DYNDC1182B PICC INSERTION TRAY DYNDC1251D CENTRAL LINE TRAY DYNDC1251D CENTRAL LINE TRAY DYNDC1586C CENTRAL LINE DRESSING NGE TRAY DYNDC1597A CVC DRESSING CHANGE TRAY DYNDC1796C TRAY, CENTRAL LINE DYNDC1796C TRAY, CENTRAL LINE DYNDC1800 TRAY,PORT-A-CATH ACCESS DYNDC1855A CVC DRESSING CHANGE KIT DYNDC1870A SMALL DRESSING KIT DYNDC1945B PORT ACCESS KIT DYNDC1980B CVC DRESSING CHANGE KIT DYNDC1980B CVC DRESSING CHANGE KIT DYNDC1993 PORT ACCESS TRAY DYNDC1993 PORT ACCESS TRAY DYNDC1993 PORT ACCESS TRAY DYNDC1993 PORT ACCESS TRAY DYNDC1996B CENTRAL LINE DRESSING CHANGE DYNDC2004A IVAD KIT DYNDC2063D CENTRAL LINE DRESSING KIT DYNDC2063D CENTRAL LINE DRESSING KIT DYNDC2078 VAD DRESSING CHANGE TRAY DYNDC2078 VAD DRESSING CHANGE TRAY DYNDC2078 VAD DRESSING CHANGE TRAY DYNDC2078 VAD DRESSING CHANGE TRAY DYNDC2122B NEONATAL DRESSING CHANGE TRAY DYNDC2208C PEDIATRIC CENTRAL LINE SMALL DYNDC2215 DRESSING CHANGE W/CHG DYNDC2253 CENTRAL LINE DRESSING CHANGE DYNDC2278 CENTRAL LINE DRESSING CHANGE DYNDC2279 A LINE DRESSING CHANGE DYNDC2325A CVC DRESSING CHANGE DYNDC2338A PORT ACCESS KIT DYNDC2338A PORT ACCESS KIT DYNDC2396 CENTRAL LINE CAP CHANGE KIT DYNDC2451 PORT ACCESS KIT W/SALINE DYNDC2464B PORT DRESSING CHANGE KIT DYNDC2521 DRESSING CHANGE KIT SM LF 1921 DYNDC2523 IMPLANTED PORT ACCESS KIT DYNDC2523 IMPLANTED PORT ACCESS KIT DYNDC2597A PHC IMPLANTED PORT TRAY DYNDC2597A PHC IMPLANTED PORT TRAY DYNDC2625 CNTRL LINE DRSG CHG/PORT KIT DYNDC2639 CENTRAL LINE CANCER CENTER DYNDC2645 LVAD KIT DYNDC2651A CENTRAL LINE/PICC DRSG CHG KIT LARGE DYNDC2691 Angio Port Kit w/High Grade Instruments

How much: “N/A”, in FDA’s words.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Codes to check against yours

Lot Numbers: DYNDC1182B PICC INSERTION TRAY 2019020590 DYNDC1251D CENTRAL LINE TRAY 2019032590 DYNDC1251D CENTRAL LINE TRAY 2019020590 DYNDC1586C CENTRAL LINE DRESSING NGE TRAY 2019011590 DYNDC1597A CVC DRESSING CHANGE TRAY 2019032990…

Every code shown here, 1,998 characters

Lot Numbers: DYNDC1182B PICC INSERTION TRAY 2019020590 DYNDC1251D CENTRAL LINE TRAY 2019032590 DYNDC1251D CENTRAL LINE TRAY 2019020590 DYNDC1586C CENTRAL LINE DRESSING NGE TRAY 2019011590 DYNDC1597A CVC DRESSING CHANGE TRAY 2019032990 DYNDC1796C TRAY, CENTRAL LINE 2019031490 DYNDC1796C TRAY, CENTRAL LINE 2019012890 DYNDC1800 TRAY,PORT-A-CATH ACCESS 2018120490 DYNDC1855A CVC DRESSING CHANGE KIT 2018120490 DYNDC1870A SMALL DRESSING KIT 2019022590 DYNDC1945B PORT ACCESS KIT 2019012590 DYNDC1980B CVC DRESSING CHANGE KIT 2019041190 DYNDC1980B CVC DRESSING CHANGE KIT 2018121890 DYNDC1993 PORT ACCESS TRAY 2019031880 DYNDC1993 PORT ACCESS TRAY 2019030580 DYNDC1993 PORT ACCESS TRAY 2019030480 DYNDC1993 PORT ACCESS TRAY 2019012880 DYNDC1996B CENTRAL LINE DRESSING CHANGE 2018120590 DYNDC2004A IVAD KIT 2019013090 DYNDC2063D CENTRAL LINE DRESSING KIT 2019020590 DYNDC2063D CENTRAL LINE DRESSING KIT 2018092890 DYNDC2078 VAD DRESSING CHANGE TRAY 2019050680 DYNDC2078 VAD DRESSING CHANGE TRAY 2019030480 DYNDC2078 VAD DRESSING CHANGE TRAY 2019022580 DYNDC2078 VAD DRESSING CHANGE TRAY 2019011480 DYNDC2122B NEONATAL DRESSING CHANGE TRAY 2019060390 DYNDC2208C PEDIATRIC CENTRAL LINE SMALL 2018092590 DYNDC2215 DRESSING CHANGE W/CHG 2019010490 DYNDC2253 CENTRAL LINE DRESSING CHANGE 2018112690 DYNDC2278 CENTRAL LINE DRESSING CHANGE 2019022890 DYNDC2279 A LINE DRESSING CHANGE 2019050890 DYNDC2325A CVC DRESSING CHANGE 2018122190 DYNDC2338A PORT ACCESS KIT 2019031880 DYNDC2338A PORT ACCESS KIT 2019030480 DYNDC2396 CENTRAL LINE CAP CHANGE KIT 2018110690 DYNDC2451 PORT ACCESS KIT W/SALINE 2018122890 DYNDC2464B PORT DRESSING CHANGE KIT 2019032090 DYNDC2521 DRESSING CHANGE KIT SM LF 1921 2019022090 DYNDC2523 IMPLANTED PORT ACCESS KIT 2018121790 DYNDC2523 IMPLANTED PORT ACCESS KIT 2018100590 DYNDC2597A PHC IMPLANTED PORT TRAY 2019030190 DYNDC2597A PHC IMPLANTED PORT TRAY 2018122690 DYNDC2625 CNTRL LINE DRSG CHG/PORT KIT 2019032090 DYNDC2639 CENTRAL LINE CANCER CENTER 2019012490 DYNDC2645 LVAD KIT…

FDA’s list runs to 2,128 characters. The first part is shown; the rest is on FDA’s record.

Source:

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.

Nationwide Foreign: GHANA

These words name no state.

What FDA means by nationwide

“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”

openFDA, its enforcement report fields.

The words say it went outside the United States too.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

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.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

  • The firm began the recall on Dec 11, 2019.
  • FDA classified it on Feb 5, 2020.
  • FDA’s Enforcement Report published it on Feb 12, 2020.
  • FDA terminated it on Sep 4, 2020.
Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Who is recalling it?

  • Centurion Medical Products Corporation, of Williamston, MI.
  • Who began it, in FDA’s words: Voluntary: Firm initiated.
  • How the firm first told its customers: Letter.
Source:

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 2,128 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.
Source:

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.

Source:

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.

How to read a record

Four things every record does, shown on an example record made up for this guide.

An example record, made up for this guide

An example nursing home

Made up for this guide: no real place is shown

Not fully inspected in over two years (CMS flag)

11 health citations at the latest inspection cycle

The state average is 14.3.

Source:

CMS, State and US Averages and Health Deficiencies. Released Oct 28, 2026. Updated monthly.

From the homeNone yet. Replies and paid listings aren’t open, and when they open they will sit here, below the record.

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Every fact names its source.

Who published it, when, and how often it changes sit beside each fact, with a link to the agency’s own file.

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