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FDA Medical Device Recalls (openFDA)

Centurion Medical Products Corporation: TRIPLE LUMEN CVC 20CM BUNDLE STCVC2040

Recall number
Z-0106-2020
Recalling firm
Centurion Medical Products Corporation
Product
TRIPLE LUMEN CVC 20CM BUNDLE STCVC2040
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
2018110150 2018120350 2018121050 2019021150 2019021550
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

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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

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