Food, drugs, devices › Centurion Medical Products Corporation

Device recall: 0.9% Sodium Chloride Injection, USP BD PosiFlush(TM) SF Saline Flush Syringe 10 mL REF#306553 used in Centurion Convenie

FDA enforcement event 68989 · Class II · initiated 25 Jul 2014 · status Terminated · terminated 25 Nov 2014

DeviceVoluntary: Firm initiated1 product recordWilliamston, MI

FDA enforcement event 68989 is a device recall by Centurion Medical Products Corporation of Williamston, MI, initiated 25 Jul 2014 and classified Class II, with 1 product record.

FDA defines Class II as 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. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.

Status: Terminated, terminated 25 Nov 2014. Initiation: voluntary: firm initiated. Centurion Medical Products Corporation has 19 enforcement events on this register, with a median of 2 product records per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Centurion Medical Products Corporation, Williamston, MI.

Reason for recall

"Unit packages may exhibit open seals which impacts package integrity and potentially product sterility."

Distribution

"The product was distributed domestically to the following states: UT, WI, TX, NE, AZ, CA, IA, MD, NY, OK, PA, TN, TX, VA, NC, IL, MA, OR, WA, IN, SD."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-2670-2014	0.9% Sodium Chloride Injection, USP BD PosiFlush(TM) SF Saline Flush Syringe 10 mL REF#306553 used in Centurion Convenience Kits. Recalled product is attached to the outside of the Convenience Kits.	21388	Class II	Terminated	1 Oct 2014

Context

91%of 2014 device events are Class II1,176 events that year

1product record in this eventfirm median: 2

19events on this register for the firm

Other enforcement events for 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
24 Apr 2019	PICC Line Accessory Kit CVI4285	Device	Class II	33
29 Mar 2019	Sterile Nail Clipper Concave Edge (67710)	Device	Class II	2

All 19 events for Centurion Medical Products Corporation

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Unit packages may exhibit open seals which impacts package integrity and potentially product sterility."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is 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.

Where was the product distributed?

FDA's distribution pattern field reads: "The product was distributed domestically to the following states: UT, WI, TX, NE, AZ, CA, IA, MD, NY, OK, PA, TN, TX, VA, NC, IL, MA, OR, WA, IN, SD."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 25 Nov 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.