PlainRecalls
FDA Devices Verify with FDA Devices → Moderate Class II Terminated

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 DT1227

Reported: February 12, 2020 Initiated: December 11, 2019 #Z-1047-2020 N/A units

Centurion Medical Products Corporation issued this FDA Devices recall on February 12, 2020. Classified as Moderate severity (Class II). Approximately N/A units are affected. The recall was issued because: Incomplete seals on the sterile package may compromise the sterility. 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-1047-2020) was formally reported on February 12, 2020, with the manufacturer initiating the action on December 11, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Centurion Medical Products Corporation is listed as the recalling firm, operating out of Williamston, MI. Federal records indicate N/A units are affected.

The documented reason for this recall is: Incomplete seals on the sterile package may compromise the sterility Distribution data in the federal record shows the product reached: Nationwide Foreign: GHANA. 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.

Recall Distribution by Severity Class

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

Severity

Moderate

Units Affected

N/A

Related Recalls

6

6 from same agency

Product Description

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

Reason for Recall

Incomplete seals on the sterile package may compromise the sterility

Details

Units Affected
N/A
Distribution
Nationwide Foreign: GHANA
Location
Williamston, MI

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number Z-1047-2020
Date reported February 12, 2020
Date initiated December 11, 2019
Recalling firm Centurion Medical Products Corporation
Units affected N/A
Distribution Nationwide Foreign: GHANA

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? ▼
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. Recalled by Centurion Medical Products Corporation. Units affected: N/A.
Why was this product recalled? ▼
Incomplete seals on the sterile package may compromise the sterility
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 12, 2020. Severity: Moderate. Recall number: Z-1047-2020.
Where was the recalled product distributed? ▼
Distribution: Nationwide Foreign: GHANA.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1047-2020) 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.

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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).