Z-1079-2018Class II

SUTURE REMOVAL TRAY, SET or KIT

Name: Z-1079-2018 SUTURE REMOVAL TRAY, SET or KIT
Creator: Centurion Medical Products Corporation
Published: 2017-10-23
License: https://open.fda.gov/license/

Centurion Medical Products, LP / initiated 2017-10-23 / Terminated / root cause: manufacturing process

FDA source

Centurion Medical Products Corporation began a recall of SUTURE REMOVAL TRAY, SET or KIT on 2017-10-23. FDA classified it as Class II and gives the reason as "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". 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-1079-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-23
Posted: 2018-03-17
Terminated: 2018-06-21
Recalling firm: Centurion Medical Products, LP
Product: SUTURE REMOVAL TRAY, SET or KIT
Product code: MCZ Suture Removal Kit
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On October 16, 2017 a PRODUCT CORRECTION letter was issued to customers notifying them that if they had any kits in their inventory, Centurion will supply labels to affix to the front of each kit instructing the user to discard the prep pad upon opening the kit. Other components of the kit may continue to be used and are NOT within the scope of this recall.
Distribution: Nationally
Product codes and lots: 55160 55395 55525 60125 60255 60360 60365 75435 84105 86125 SR530 Lot codes: 2016011801 2016011290 2016022390 2016042990 2016061390 2016080390 2016101790 2017011090 2015111990 2017022790 2015062201 2015081001 2016032101 2016050901 2016091201 2017032001 2017061501 2015042701 2015100501 2015120701 2016011101 2016071101 2016103101 2017011601 2017071201 2015100501 2016012501 2016071101 2016090501 2017013101 2017021601 2017051101 2017080701 2016060601 2017071101 2015111601 2016030701 2016101001 2015062201 2015110201 2016022201 2016091201 2015050401 2015082401 2016010401 2016072501 2017042401 2016101001 2017021301 2017071101 2016050201 2016111401 2015062901 2015081701 2015090701 2015110201 2016021501 2016040401 2016071101 2016102401 2016121401 2017021301 2017041901 2017070501 2017071801 2015072001 2016111401 2016021501 2016062001 2016081501 2016062701 2016040790 2015102990 2015120790 2016011890 2016050990 2016072590 2016091990 2017010390 2017012390 2017052290 2017062290 2015061501 2015081001 2015102601 2015122801 2016030701 2016050901 2016072501 2016101001 2016122701 2017041201 2017071001 2015060801 2015072001 2015082401 2015102601 2015122801 2016022201 2016050201 2016072501 2016091201 2016110701 2017022801 2017053101 2017060501 2016122001 2017041101

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1079-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1078-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-17
Z-1079-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-17
Z-1080-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-17
Z-1081-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-17
Z-1082-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-17
Z-1083-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-17
Z-1084-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-17
Z-1085-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-17
Z-1086-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-17
Z-1087-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-17
Z-1088-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-17
Z-1089-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-17
Z-1090-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-17
Z-1091-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-17
Z-1092-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-17
Z-1093-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-17
Z-1094-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-17
Z-1095-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-17
Z-1096-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-17
Z-1097-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-17
Z-1098-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-17

Product code MCZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)