FDA Medical Device Recalls (openFDA)
Centurion Medical Products Corporation: CVC BUNDLE VANTEX 7F, 3L, 20CM ECVC6065
- Recall number
- Z-0094-2020
- Recalling firm
- Centurion Medical Products Corporation
- Product
- CVC BUNDLE VANTEX 7F, 3L, 20CM ECVC6065
- Status
- Terminated
- Initiated
- 2019-04-24
- Posted
- not on file
- Terminated
- 2020-04-03
- Reason
- Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.
- Root cause
- Under Investigation by firm
- Action
- On April 24, 2019, the firm notified customers who had received kits containing BD's MaxZero product. Customers were instructed to do the following: 1. Whether or not you have product in inventory, please complete and return the attached Centurion Accountability Record via email- lcarpenter@centurionmp.com or via fax-517-546-3356. 2. Please share this communication with all users of the product within your organization, as directed in the BD letter. 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. Web: MedWatch website at www.fda.gov/medwatch Phone: 1-800-FDA-1088 (1- 800-332-1088); Mail: MedWatch, HF-2, FDA, 5600 Fisher's Lane, Rockville, MD 20852- 9787
- Quantity
- 181965 total
- Distribution
- Nationwide domestic distribution.
- Lot, serial or model codes
- 2018082450 2018091850 2018121850 2018122150 2019011550 2019012450 2019013050
- 510(k) numbers
- ["K171957"]
- PMA numbers
- not on file
- Product code
- OES
- 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