Centurion- Dressing Change Tray DT10290S CENTRAL LINE PREPARATION PACK DT10290S CENTRAL LINE PREPARATION PACK…
Medical device recall Z-1047-2020. Published in FDA’s Enforcement Report on Feb 12, 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 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.
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
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Centurion- Dressing Change Tray DT10290S CENTRAL LINE PREPARATION PACK DT10290S CENTRAL LINE PREPARATION PACK DT10415 PICC INSERTION TRAY DT10495 PICC INSERTION TRAY DT10525 CENTRAL LINE INSERTION DRAPE KIT DT10675 CENTRAL LINE INSERTION PROCEDURE KIT DT10755 DRESS UP KIT DT10850 PORT DRESSING CHANGE TRAY DT10850 PORT DRESSING CHANGE TRAY DT11300 DIALYSIS ON/OFF KIT DT11610 DRESSING CHANGE TRAY DT11955 UNIVERSAL LINE FULL BODY DRAPE KIT - REG DT12220 CVC DRESSING CHANGE TRAY DT12270 DRESSING CHANGE TRAY DT12270 DRESSING CHANGE TRAY DT12415 NEONATAL PICC INSERTION TRAY DT12415 NEONATAL PICC INSERTION TRAY DT12485 PEDI CENT LINE TRAY W/SORB SHIELD DT12540 CENTRAL LINE PACK DT12555 UNIVERSAL CVC INS SUPP TRAY DT12725 CENTRAL LINE DRESSING TRAY DT12900 CL / PICC DRESSING CHANGE TRAY DT13005A CVC DRESSING CHANGE TRAY DT13055 PICC/CENTRAL LINE DRESSING CHANGE DT13055 PICC/CENTRAL LINE DRESSING CHANGE DT13055 PICC/CENTRAL LINE DRESSING CHANGE DT13125 CENTRAL LINE TRAY DT13525 DRESSING CHANGE TRAY DT13560 PORT ACCESS TRAY DT13560 PORT ACCESS TRAY DT13560 PORT ACCESS TRAY DT13635 DRESSING CHANGE TRAY DT13725 ON/OFF KITS DT13835 DRESSING CHANGE TRAY W/BIOPATCH DT13885 DRESSING CHANGE TRAY DT14065 CVC KIT DT14100 CENTRAL LINE DSG CHG TRAY W/BIOPATCH DT14135 PICC/CVC DRSG CHNG TRAY W/SORB SHIELD DT14180 UNIVERSAL CATHETER INSERTION SET DT14215 CVC LINE DRESSING CHANGE DT14215 CVC LINE DRESSING CHANGE DT14380 PICC MAINTENANCE PACK DT14470 CVC DRSG CH W/BIOPATCH & SORB SHLD DT14500 CENTRAL LINE DRESSING CHANGE TRAY DT14500 CENTRAL LINE DRESSING CHANGE TRAY DT14500 CENTRAL LINE DRESSING CHANGE TRAY DT14650 MAXIMUM PROTECTION KIT DT14865 PORT CATH FLUSH KIT DT14965 PROCEDURE KIT DT15160 ADULT PORT FLUSH KIT DT15370 IN-PATIENT VAD KIT DT15370 IN-PATIENT VAD KIT DT15600 DRESSING CHANGE TRAY DT15605A CVC DRESSING CHANGE TRAY DT15655 CVC INSERTION TRAY DT15775 NICU PICC LINE DRESSING CHANGE KIT DT15780A PORT AND IO ACCESS DRESSING KIT DT15970 MAXIMUM PROTECTION KIT DT15970 MAXIMUM PROTECTION KIT DT15975 CENTRAL LINE INSERTION KIT DT15995 BOND CLINIC PORT DRESSING TRAY DT16435 CENTRAL LINE DRESSING KIT DT16480 PICC CENTRAL CVC CHANGE TRAY DT16550 ICU ARTERIAL LINE TRAY DT16550 ICU ARTERIAL LINE TRAY DT17055 CENTRAL LINE ACCESSORY PACK DT17120 VAD ACCESS KIT DT17135 NEONATAL DRESSING CHANGE TRAY DT17265 SUBC/PICC DRESS TRAY W/4MM BIOPATCH DT17365 SINGLE PORT ACCESS TRAY DT17380 IJ VAS-CATH DRESSING CHANGE TRAY DT17410 ON/OFF KIT & DRESSING CHANGE TRAY DT17420 ACCESS PORT KIT DT17500 PICC DRESSING KIT DT17675 DRIVELINE MANAGEMENT SYSTEM W/O BIOPATCH DT17745 DRESSING CHANGE TRAY DT17850 PORT DRESSING TRAY WITH BIOPATCH DT17870 WEEKLY DRIVELINE MANAGEMENT SYSTEM DT17965 PORT ACCESS TRAY DT18030 PORT ACCESS TRAY DT18375 DRIVELINE MANAGEMENT SYSTEM (W) DT18395 PORT ACCESS TRAY DT18415 PORT DRESSING CHANGE TRAY DT18450 PORT ACCESS DRESSING CHANGE TRAY DT18545 PORT DRESSING CHANGE TRAY DT18600 DRIVELINE MANAGEMENT SYSTEM w/CHG DT18600 DRIVELINE MANAGEMENT SYSTEM w/CHG DT18655 DAILY LVAD DRESSING KIT DT18675 LVAD MANAGEMENT SYSTEM-WEEKLY DT18690 DRIVELINE MANAGEMENT SYSTEM DT18690 DRIVELINE MANAGEMENT SYSTEM DT18695A DRIVELINE MGMT. KIT WITH SILVER ALGINATE DT18775 PORT ACCESS TRAY DT19625 PORT ACCESS TRAY DT19665 CENTRAL LINE DRESSING CHANGE KIT DT19665 CENTRAL LINE DRESSING CHANGE KIT DT19820 PEDIATRIC DRESSING CHANGE TRAY DT19835A PEDIATRIC PORT ACCESS BUNDLE DT19840 PORT ACCESS TRAY DT19900 CENTRAL LINE DRESSING CHANGE OVAL SHIELD DT20060 PORT ACCESS KIT DT20100 PORT ACCESS TRAY W/SECUREVIEW DT20160 PORT ACCESS KIT DT20335 KAISER CENTRAL LINE MANAGEMENT SYSTEM DT20335 KAISER CENTRAL LINE MANAGEMENT SYSTEM DT20350A DIALYSIS OFF KIT DT20370A CVC/PORT ACCESS TRAY DT20385 CENTRAL LINE DRESSING KIT DT20405 PICU MAX BARRIER KIT DT20480 PICC AND PORT DRESSING KIT DT20570 CENTRAL LINE CARE & MAINTENANCE BUNDLE DT20640 PORT DRESSING CHANGE TRAY DT20
How much: “N/A”, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lot Numbers: DT10290S CENTRAL LINE PREPARATION PACK 2019052490 DT10290S CENTRAL LINE PREPARATION PACK 2019020890 DT10415 PICC INSERTION TRAY 2018120390 DT10495 PICC INSERTION TRAY 2018121490 DT10525 CENTRAL LINE INSERTION DRAPE KIT…
Every code shown here, 2,000 characters
Lot Numbers: DT10290S CENTRAL LINE PREPARATION PACK 2019052490 DT10290S CENTRAL LINE PREPARATION PACK 2019020890 DT10415 PICC INSERTION TRAY 2018120390 DT10495 PICC INSERTION TRAY 2018121490 DT10525 CENTRAL LINE INSERTION DRAPE KIT 2018122690 DT10675 CENTRAL LINE INSERTION PROCEDURE KIT 2019020890 DT10755 DRESS UP KIT 2019040290 DT10850 PORT DRESSING CHANGE TRAY 2019022090 DT10850 PORT DRESSING CHANGE TRAY 2019013190 DT11300 DIALYSIS ON/OFF KIT 2019032190 DT11610 DRESSING CHANGE TRAY 2018100390 DT11955 UNIVERSAL LINE FULL BODY DRAPE KIT - REG 2019020590 DT12220 CVC DRESSING CHANGE TRAY 2019030790 DT12270 DRESSING CHANGE TRAY 2019061490 DT12270 DRESSING CHANGE TRAY 2019050990 DT12415 NEONATAL PICC INSERTION TRAY 2019050690 DT12415 NEONATAL PICC INSERTION TRAY 2019042490 DT12485 PEDI CENT LINE TRAY W/SORB SHIELD 2019011490 DT12540 CENTRAL LINE PACK 2019021190 DT12555 UNIVERSAL CVC INS SUPP TRAY 2019052890 DT12725 CENTRAL LINE DRESSING TRAY 2019011790 DT12900 CL / PICC DRESSING CHANGE TRAY 2019010490 DT13005A CVC DRESSING CHANGE TRAY 2019060590 DT13055 PICC/CENTRAL LINE DRESSING CHANGE 2019031290 DT13055 PICC/CENTRAL LINE DRESSING CHANGE 2019021290 DT13055 PICC/CENTRAL LINE DRESSING CHANGE 2018121090 DT13125 CENTRAL LINE TRAY 2019012890 DT13525 DRESSING CHANGE TRAY 2019032590 DT13560 PORT ACCESS TRAY 2019031490 DT13560 PORT ACCESS TRAY 2019011590 DT13560 PORT ACCESS TRAY 2018100590 DT13635 DRESSING CHANGE TRAY 2019040290 DT13725 ON/OFF KITS 2018100190 DT13835 DRESSING CHANGE TRAY W/BIOPATCH 2019022590 DT13885 DRESSING CHANGE TRAY 2019010290 DT14065 CVC KIT 2019031290 DT14100 CENTRAL LINE DSG CHG TRAY W/BIOPATCH 2019030890 DT14135 PICC/CVC DRSG CHNG TRAY W/SORB SHIELD 2018100890 DT14180 UNIVERSAL CATHETER INSERTION SET 2019012390 DT14215 CVC LINE DRESSING CHANGE 2019010490 DT14215 CVC LINE DRESSING CHANGE 2018121790 DT14380 PICC MAINTENANCE PACK 2019050680 DT14470 CVC DRSG CH W/BIOPATCH & SORB SHLD 2019021290 DT14500 CENTRAL LINE DRESSING CHANGE TRAY 2019013190 DT14500…
FDA’s list runs to 7,402 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.
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.
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.
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.
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.
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 7,402 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.