Z-0095-2020Class II

Cvc Triple Lumen Safety Bundle Ecvc6070

Name: Z-0095-2020 Cvc Triple Lumen Safety Bundle Ecvc6070
Creator: Centurion Medical Products Corporation
Published: 2019-04-24
License: https://open.fda.gov/license/

Centurion Medical Products, LP / initiated 2019-04-24 / Terminated / root cause: manufacturing process

FDA source

Centurion Medical Products Corporation began a recall of CVC TRIPLE LUMEN SAFETY BUNDLE ECVC6070 on 2019-04-24. FDA classified it as Class II and gives the reason as "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...". 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-0095-2020
Classification: Class II
Status: Terminated
Initiated: 2019-04-24
Posted: 2019-10-09
Terminated: 2020-04-03
Recalling firm: Centurion Medical Products, LP
Product: Cvc Triple Lumen Safety Bundle Ecvc6070
Product code: OES Cardiac Catheterization Kit
Reason for recall: 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 tag: manufacturing process
FDA 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- [email protected] 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 in commerce: 181965 total
Distribution: Nationwide domestic distribution.
Product codes and lots: 2018081550 2018091750 2018100850

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0095-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0075-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-09
Z-0076-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-09
Z-0077-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-09
Z-0078-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-09
Z-0079-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-09
Z-0080-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-09
Z-0081-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-09
Z-0082-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-09
Z-0083-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-09
Z-0084-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-09
Z-0085-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-09
Z-0086-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-09
Z-0087-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-09
Z-0088-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-09
Z-0089-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-09
Z-0090-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-09
Z-0091-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-09
Z-0092-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-09
Z-0093-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-09
Z-0094-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-09
Z-0095-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-09
Z-0096-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-09
Z-0097-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-09
Z-0098-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-09
Z-0099-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-09
Z-0100-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-09
Z-0101-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-09
Z-0102-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-09
Z-0103-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-09
Z-0104-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-09
Z-0105-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-09
Z-0106-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-09
Z-0107-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-09

Product code OES

K171957Class IIMaxZero Extension Sets with Needless ConnectorCarefusion 303, Inc. / cleared 2017-07-19

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)