Device recall: PICC Line Accessory Kit CVI4285

Class II FDA enforcement event 83584. Recall start date: 24 Apr 2019. Status in the FDA record: Terminated. Termination date: 3 Apr 2020.

Reason for recall, in the words of FDA

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.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Centurion Medical Products Corporation started this device recall on 24 Apr 2019. The firm address in the FDA record is in Williamston, MI. FDA put the recall in Class II. FDA event 83584 has 33 product records. The first FDA enforcement report date is 16 Oct 2019. The record gives the status Terminated, with the termination date 3 Apr 2020.

FDA enforcement report The 33 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide domestic distribution.

Recalling firm

Centurion Medical Products Corporation, Williamston, MI.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

33 product records in the event.

FDA event 83584: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0075-2020	PICC Line Accessory Kit CVI4285	181965	Class II	Terminated	16 Oct 2019
Z-0076-2020	PEDIATRIC PICC INSERTION TRAY CVI4450	181965	Class II	Terminated	16 Oct 2019
Z-0077-2020	PEDIATRIC PICC INSERTION TRAY CVI4450A	181965 total	Class II	Terminated	16 Oct 2019
Z-0078-2020	NEONATAL PROCEDURE TRAY PICC CATHETERS CVI4535	181965 total	Class II	Terminated	16 Oct 2019
Z-0079-2020	CVC BUNDLE WITHOUT CATH CVI4600	181965 total	Class II	Terminated	16 Oct 2019
Z-0080-2020	PORT AND IO ACCESS DRESSING KIT DT15780A	181965 total	Class II	Terminated	16 Oct 2019
Z-0081-2020	Cap Change Kit DT20310	181965 total	Class II	Terminated	16 Oct 2019
Z-0082-2020	Neonatal Cap Change Kit DT20315	181965 total	Class II	Terminated	16 Oct 2019
Z-0083-2020	CAP CHANGE KIT DYNDC1496B	181965 total	Class II	Terminated	16 Oct 2019
Z-0084-2020	INFUSA PORT KIT DYNDC1840E	181965 total	Class II	Terminated	16 Oct 2019
Z-0085-2020	INFUSA PORT KIT DYNDC1840F	181965 total	Class II	Terminated	16 Oct 2019
Z-0086-2020	STERILE CAP CHANGE KIT DYNDC1946B	181965 total	Class II	Terminated	16 Oct 2019
Z-0087-2020	CAP BUNDLE KIT DYNDC2137	181965 total	Class II	Terminated	16 Oct 2019
Z-0088-2020	TRIPLE LUMEN BUNDLE KIT ECVC1540	181965 total	Class II	Terminated	16 Oct 2019
Z-0089-2020	CENTRAL VENOUS ACCESS DEVICE BUNDLE ECVC2840	181965 total	Class II	Terminated	16 Oct 2019
Z-0090-2020	CVC BUNDLE, 20CM, 4L, PI ECVC5095	181965 total	Class II	Terminated	16 Oct 2019
Z-0091-2020	CVC BUNDLE, 20CM, 3L, PI ECVC5120	181965 total	Class II	Terminated	16 Oct 2019
Z-0092-2020	CVC BUNDLE, 20CM, 3L, PI ECVC5120A	181965 total	Class II	Terminated	16 Oct 2019
Z-0093-2020	CVC BUNDLE MULTIMED, 3L, 20CM ECVC6060	181965 total	Class II	Terminated	16 Oct 2019
Z-0094-2020	CVC BUNDLE VANTEX 7F, 3L, 20CM ECVC6065	181965 total	Class II	Terminated	16 Oct 2019
Z-0095-2020	CVC TRIPLE LUMEN SAFETY BUNDLE ECVC6070	181965 total	Class II	Terminated	16 Oct 2019
Z-0096-2020	CVC INSERTION BUNDLE 8.5FR 4L 16CM ECVC6355	181965 total	Class II	Terminated	16 Oct 2019
Z-0097-2020	CENTRAL LINE BUNDLE ECVC6375	181965 total	Class II	Terminated	16 Oct 2019
Z-0098-2020	CENTRAL LINE BUNDLE 16CM MULTIMED ECVC6545	181965 total	Class II	Terminated	16 Oct 2019
Z-0099-2020	CENTRAL LINE BUNDLE 16CM MULTIMED ECVC6545A	181965 total	Class II	Terminated	16 Oct 2019
Z-0100-2020	OR VANTEX 7FR 3L 16CM CVC ECVC6665	181965 total	Class II	Terminated	16 Oct 2019
Z-0101-2020	VANTEX 7FR, 16CM, 3L CVC BUNDLE ECVC6670	181965 total	Class II	Terminated	16 Oct 2019
Z-0102-2020	IV START KIT IV8440	181965 total	Class II	Terminated	16 Oct 2019
Z-0103-2020	IV SECUREMENT KIT IVS3405	181965 total	Class II	Terminated	16 Oct 2019
Z-0104-2020	IV KIT - SORBAVIEW IVS3475	181965 total	Class II	Terminated	16 Oct 2019
Z-0105-2020	INVASIVE PROCEDURE TRAY MNS9510	181965 total	Class II	Terminated	16 Oct 2019
Z-0106-2020	TRIPLE LUMEN CVC 20CM BUNDLE STCVC2040	181965 total	Class II	Terminated	16 Oct 2019
Z-0107-2020	UVC TRAY UVT875	181965 total	Class II	Terminated	16 Oct 2019

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2019: 968
Share of these events in Class II: 88%
Product records in this event: 33Median of the firm: 2
Events of the firm on the register: 19

Other events of the firm

Other FDA enforcement events of Centurion Medical Products Corporation
Initiated	Product (first record)	Type	Class	Records
11 Dec 2019	Centurion Circumsion Trays as follows: Kit Code Product CIT1270 CIRCUMCISION TRAY CIT2365 CIRCUMCISION TRAY CIT2465 CIRC	Device	Class II	54
24 Oct 2019	Centurion Medical Products UNIVERSAL LINE FULL BODY DRAPE KIT - REG Code: DT11955	Device	Class II	1
28 Aug 2019	Centurion CIRCLAMP W/1.1CM BELL - single-use, disposable instrument used to compress the foreskin of the penis during ci	Device	Class II	2
15 Jul 2019	Port full Access Tray Product Code: DT19330	Device	Class II	4
1 Jul 2019	STERILE GRAVES VAGINAL SPECULUM MEDIUM Kit Code # GVS10MST - Product Usage:The speculum is used to spread the walls of t	Device	Class II	13
24 Jun 2019	EPISTAXIS TRAY Kit Code: MNS10165	Device	Class II	3
7 Jun 2019	Sheridan Endotracheal Tube contained inside Centurion kit code TC7855.	Device	Class I	1
1 Jun 2019	Centurion DIFFICULT IV KIT containing BD's Vacutainer Plastic Lithium Heparin Tubes (BD Vacutainer-BD Codes 367884 & 367	Device	Class II	1
29 Mar 2019	Sterile Nail Clipper Concave Edge (67710)	Device	Class II	2
23 Oct 2017	SKIN STAPLE REMOVER	Device	Class II	21

Centurion Medical Products Corporation: all 19 events

Official channels

FDA enforcement report Z-0075-2020The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 83584. https://recallregister.com/fda/ii/83584/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide domestic distribution.
What quantity of product is in FDA event 83584?: The event has 33 product records. The first record gives this quantity: 181965
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2019 have the same class?: 88% of the 968 device events that started in 2019 are in Class II.