Food, drugs, devices › Centurion Medical Products Corporation

Device recall: EPISTAXIS TRAY Kit Code: MNS10165

FDA enforcement event 83359 · Class II · initiated 24 Jun 2019 · status Terminated · terminated 24 Jul 2020

DeviceVoluntary: Firm initiated3 product recordsWilliamston, MI

FDA enforcement event 83359 is a device recall by Centurion Medical Products Corporation of Williamston, MI, initiated 24 Jun 2019 and classified Class II, with 3 product records.

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. 88% of the 968 device enforcement events initiated in 2019 carry the same class.

Status: Terminated, terminated 24 Jul 2020. 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

"Various medical device kits contain MAJOR Nasal Decongestant Spray is being recalled by the manufacturer"

Distribution

"CT, IL"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0407-2020	EPISTAXIS TRAY Kit Code: MNS10165	525 Kits	Class II	Terminated	27 Nov 2019
Z-0408-2020	YNHH SCOPE KIT Kit Code: MNS10475	644 Kits	Class II	Terminated	27 Nov 2019
Z-0409-2020	NOSEBLEED TRAY Kit Code: MNS3885	30 Kits	Class II	Terminated	27 Nov 2019

Context

88%of 2019 device events are Class II968 events that year

3product records 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
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
23 Oct 2017	SKIN STAPLE REMOVER	Device	Class II	21

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: "Various medical device kits contain MAJOR Nasal Decongestant Spray is being recalled by the manufacturer"

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: "CT, IL"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 24 Jul 2020. "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.