Z-0254-2020Class II

Maintenance Flush Kit/Blood Draw

Name: Z-0254-2020 Maintenance Flush Kit/Blood Draw
Creator: Centurion Medical Products Corporation
Published: 2019-07-15
License: https://open.fda.gov/license/

Centurion Medical Products, LP / initiated 2019-07-15 / Terminated / root cause: manufacturing process

FDA source

Centurion Medical Products Corporation began a recall of Maintenance Flush Kit/Blood Draw Product Code: DT19335 on 2019-07-15. FDA classified it as Class II and gives the reason as "Supplier initiated recall of the GRIPPER Needles". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0254-2020
Classification: Class II
Status: Terminated
Initiated: 2019-07-15
Posted: 2019-10-31
Terminated: 2020-08-31
Recalling firm: Centurion Medical Products, LP
Product: Maintenance Flush Kit/Blood Draw Product Code: DT19335
Product code: OIB Blood And Urine Collection Kit (Excludes Hiv Testing)
Reason for recall: Supplier initiated recall of the GRIPPER Needles
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 1. Please identify all inventory that you have within your possession and cease use immediately. 2. Complete the enclosed accountability record, whether or not you have product, and fax or email at your earliest convenience to the attention of Lisa Carpenter. Upon receipt of this record, Centurion Representative will contact you regarding retrieval of the product from your facility. 3. Please forward this recall information to any facilities to who this product may have been further distributed, instructing them to cease use immediately.
Quantity in commerce: 240 kits
Distribution: IL
Product codes and lots: Lot Number Expiration 2018110501 7/31/2021 2018121801 7/31/2021 2019013001 9/30/2021 2019032901 9/30/2021

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0254-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0253-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-06	2019-10-31
Z-0254-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-06	2019-10-31
Z-0255-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-06	2019-10-31
Z-0256-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-06	2019-10-31

Product code OIB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)