FDA Medical Device Recalls (openFDA)
Centurion Medical Products Corporation: 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
- Recall number
- Z-2545-2020
- Recalling firm
- Centurion Medical Products Corporation
- 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
- Status
- Terminated
- Initiated
- 2019-06-01
- Posted
- not on file
- Terminated
- 2021-06-21
- Reason
- 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
- 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 - lcarpenter@centurionmp.com 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
- 140 units
- Distribution
- US Nationwide distribution including in the state of IL.
- Lot, serial or model codes
- Lot Number: 2019050790 exp. Date: 10/31/2019
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JKA
- Firm FEI
- 3008403546
- Firm city
- Williamston
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28