Device recall: SKIN STAPLE REMOVER

Class II FDA enforcement event 79329. Recall start date: 23 Oct 2017. Status in the FDA record: Terminated. Termination date: 21 Jun 2018.

Reason for recall, in the words of FDA

Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life.

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 23 Oct 2017. The firm address in the FDA record is in Williamston, MI. FDA put the recall in Class II. FDA event 79329 has 21 product records. The first FDA enforcement report date is 28 Mar 2018. The record gives the status Terminated, with the termination date 21 Jun 2018.

FDA enforcement report The 21 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.

Nationally

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

21 product records in the event.

FDA event 79329: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1078-2018	SKIN STAPLE REMOVER	N/A	Class II	Terminated	28 Mar 2018
Z-1079-2018	SUTURE REMOVAL TRAY, SET or KIT	N/A	Class II	Terminated	28 Mar 2018
Z-1080-2018	GENERAL PURPOSE INSTRUMENT TRAY	N/A	Class II	Terminated	28 Mar 2018
Z-1081-2018	MINI PLASTICS SET	N/A	Class II	Terminated	28 Mar 2018
Z-1082-2018	CIRCUMCISION TRAY	N/A	Class II	Terminated	28 Mar 2018
Z-1083-2018	CATHETER SECUREMENT SYSTEM	N/A	Class II	Terminated	28 Mar 2018
Z-1084-2018	ST. CHRISTOPHER'S SECUREMENT SET	N/A	Class II	Terminated	28 Mar 2018
Z-1085-2018	SorbaView Shield Dressing Change Tray	N/A	Class II	Terminated	28 Mar 2018
Z-1086-2018	TUBING CHANGE KIT	N/A	Class II	Terminated	28 Mar 2018
Z-1087-2018	MINOR DRESSING CHANGE TRAY	N/A	Class II	Terminated	28 Mar 2018
Z-1088-2018	INCISION & DRAINAGE TRAY or KIT	N/A	Class II	Terminated	28 Mar 2018
Z-1089-2018	BLOOD DRAW KIT	N/A	Class II	Terminated	28 Mar 2018
Z-1090-2018	NEONATAL IV ACCESS SET	N/A	Class II	Terminated	28 Mar 2018
Z-1091-2018	LATEX FREE IV START SET	N/A	Class II	Terminated	28 Mar 2018
Z-1092-2018	PEDIATRIC IV & IV START KIT	N/A	Class II	Terminated	28 Mar 2018
Z-1093-2018	IV START KIT	N/A	Class II	Terminated	28 Mar 2018
Z-1094-2018	INFANT IV SECUREMENT KIT	N/A	Class II	Terminated	28 Mar 2018
Z-1095-2018	NEONATAL IV START KIT	N/A	Class II	Terminated	28 Mar 2018
Z-1096-2018	EXCISION TRAY	N/A	Class II	Terminated	28 Mar 2018
Z-1097-2018	WOUND CARE KIT	N/A	Class II	Terminated	28 Mar 2018
Z-1098-2018	WOUND CLOSURE TRAY - FACIAL	N/A	Class II	Terminated	28 Mar 2018

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 2017: 1,091
Share of these events in Class II: 93%
Product records in this event: 21Median 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
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

Centurion Medical Products Corporation: all 19 events

Official channels

FDA enforcement report Z-1078-2018The 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 79329. https://recallregister.com/fda/ii/79329/. 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: Nationally
What quantity of product is in FDA event 79329?: The event has 21 product records. The first record gives this quantity: N/A
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2017 have the same class?: 93% of the 1,091 device events that started in 2017 are in Class II.