Z-2545-2020Class II

Centurion DIFFICULT IV KIT containing BD's Vacutainer Plastic Lithium Heparin Tubes (BD Vacutainer-BD Codes...

Name: Z-2545-2020 Centurion DIFFICULT IV KIT containing BD's Vacutainer Plastic Lithium Heparin Tubes (BD Vacutainer-BD Codes...
Creator: Centurion Medical Products Corporation
Published: 2019-06-01
License: https://open.fda.gov/license/

Centurion Medical Products, LP / initiated 2019-06-01 / Terminated / root cause: design

FDA source

Centurion Medical Products Corporation began a recall of Centurion DIFFICULT IV KIT containing BD's Vacutainer Plastic Lithium Heparin Tubes (BD Vacutainer-BD Codes 367884 & 367960; Centurion code 45177 (VACUTAINER... on 2019-06-01. FDA classified it as Class II and gives the reason as "False elevation of carboxyhemoglobin (COHb) results in blood samples collected using BD Vacutainer Plastic Lithium Heparin tubes with the IL GEM 4000 instrument". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2545-2020
Classification: Class II
Status: Terminated
Initiated: 2019-06-01
Posted: 2020-07-09
Terminated: 2021-06-21
Recalling firm: Centurion Medical Products, LP
Product: Centurion DIFFICULT IV KIT containing BD's Vacutainer Plastic Lithium Heparin Tubes (BD Vacutainer-BD Codes 367884 & 367960; Centurion code 45177 (VACUTAINER GREEN TOP) and 84815 (VACUTAINER 3ML LT. GREEN). Centurion Kit Code: IV8860
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: False elevation of carboxyhemoglobin (COHb) results in blood samples collected using BD Vacutainer Plastic Lithium Heparin tubes with the IL GEM 4000 instrument.
Root cause tag: design
FDA root cause: Device Design
Action: Centurion Notification issued to parent company, Medline Industries, via email to Recall Team via their Corporate Headquarters on 6/18/19. Letter states reason for recall, health risk and Required Action: 1. Whether or not you have product in inventory, please complete and return the attached Accountability Record via email - [email protected] or via fax -517-546-3356. 2. Please forward the BD notice to any customer(s) that may receive these kits. 3. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program. Contact BO at 1-888-237-2762, (select Option #3 and then Option #2), between 8AM and 5PM CT Monday through Friday.
Quantity in commerce: 140 units
Distribution: US Nationwide distribution including in the state of IL.
Product codes and lots: Lot Number: 2019050790 exp. Date: 10/31/2019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2545-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2545-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-15	2020-07-09

Product code JKA

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)