Z-1048-2020Class II

Centurion-_General Surgery Trays DYNDA1127A RADIOLOGY CUT DOWN TRAY #1 DYNDA1178 ICIO TRAY DYNDA1183 AUXILARY...

Name: Z-1048-2020 Centurion-_General Surgery Trays DYNDA1127A RADIOLOGY CUT DOWN TRAY #1 DYNDA1178 ICIO TRAY DYNDA1183 AUXILARY...
Creator: Centurion Medical Products Corporation
Published: 2019-12-11
License: https://open.fda.gov/license/

Centurion Medical Products, LP / initiated 2019-12-11 / Terminated / root cause: packaging

FDA source

Centurion Medical Products Corporation began a recall of Centurion-_General Surgery Trays DYNDA1127A RADIOLOGY CUT DOWN TRAY #1 DYNDA1178 ICIO TRAY DYNDA1183 AUXILARY TOWEL PACK DYNDA1223 CUSTOM PREP CUP KIT... on 2019-12-11. FDA classified it as Class II and gives the reason as "Incomplete seals on the sterile package may compromise the sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1048-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-11
Posted: 2020-02-05
Terminated: 2020-09-04
Recalling firm: Centurion Medical Products, LP
Product: Centurion-_General Surgery Trays DYNDA1127A RADIOLOGY CUT DOWN TRAY #1 DYNDA1178 ICIO TRAY DYNDA1183 AUXILARY TOWEL PACK DYNDA1223 CUSTOM PREP CUP KIT DYNDA1223 CUSTOM PREP CUP KIT DYNDA1246A CIRCUMCISION PACK DYNDA1349A CIRCUMCISION TRAY DYNDA1388 STERILE EK DOUBLE PACK DYNDA1615 STERILE BARRIER KIT DYNDA1615 STERILE BARRIER KIT DYNDA1628 VAG DELIVERY ACCESSORY PACK DYNDA1706A CIRCUMCISION TRAY W/OUT CLAMP DYNDA1843A DISPOSABLE SUTURE TRAY FGS DYNDA1843A DISPOSABLE SUTURE TRAY FGS DYNDA1861 IR KIT DYNDA1904 PREP TRAY DYNDA2076 VEIN PROCEDURE KIT DYNDA2201 SMALL BOWL KIT DYNDA2241 CIRCUMCISION TRAY DYNDA2271 CIRCUMCISION TRAY DYNDA2361 HYSTERO PACK - RADIOLOGY WEILER DYNDA2361 HYSTERO PACK - RADIOLOGY WEILER DYNDA2418 MINOR PROCEDURE TRAY DYNDA2498 STERILE UNIVERSAL KIT
Product code: LRP Tray, Surgical
Reason for recall: Incomplete seals on the sterile package may compromise the sterility
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Centurion issued a notification emailed to Medline Industries, Centurion's parent company. Centurion issued mailing letters via First Class Mail beginning on 12/12/2019, letter states reason for recall, health risk and action to take: Please identify all inventory that you have within your possession and segregate it in a location where it cannot be accessed for use. 2) If you have transferred possession of this product to another individual, to another department or to another location in your organization, you are required by FDA regulations to notify them of this recall communication. Please ask that any affected product be returned to you for collection. 3) Affected product is not to be returned to Centurion, and should be destroyed/discarded. Document the destruction of all product on the enclosed accountability record. 4) Please complete the enclosed accountability record, whether or not you have product, and fax or email at your earliest convenience to the attention of Lisa Carpenter, Director of Quality Assurance Centurion Medical Products Corporation, (517) 546-5400 Ext.1122.
Distribution: Nationwide Foreign: GHANA
Product codes and lots: Lot Numbers: DYNDA1127A RADIOLOGY CUT DOWN TRAY #1 2019031990 DYNDA1178 ICIO TRAY 2019050690 DYNDA1183 AUXILARY TOWEL PACK 2018100390 DYNDA1223 CUSTOM PREP CUP KIT 2019031290 DYNDA1223 CUSTOM PREP CUP KIT 2019021490 DYNDA1246A CIRCUMCISION PACK 2018111290 DYNDA1349A CIRCUMCISION TRAY 2019030190 DYNDA1388 STERILE EK DOUBLE PACK 2019030890 DYNDA1615 STERILE BARRIER KIT 2019031590 DYNDA1615 STERILE BARRIER KIT 2019012390 DYNDA1628 VAG DELIVERY ACCESSORY PACK 2019040290 DYNDA1706A CIRCUMCISION TRAY W/OUT CLAMP 2019031290 DYNDA1843A DISPOSABLE SUTURE TRAY FGS 2019061090 DYNDA1843A DISPOSABLE SUTURE TRAY FGS 2019030190 DYNDA1861 IR KIT 2019022590 DYNDA1904 PREP TRAY 2019011590 DYNDA2076 VEIN PROCEDURE KIT 2018101590 DYNDA2201 SMALL BOWL KIT 2019022690 DYNDA2241 CIRCUMCISION TRAY 2019032590 DYNDA2271 CIRCUMCISION TRAY 2019031990 DYNDA2361 HYSTERO PACK - RADIOLOGY WEILER 2019050690 DYNDA2361 HYSTERO PACK - RADIOLOGY WEILER 2019030590 DYNDA2418 MINOR PROCEDURE TRAY 2019021390 DYNDA2498 STERILE UNIVERSAL KIT 2019061190

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1048-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1042-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1043-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1044-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1045-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1046-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1047-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1048-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1049-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1050-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1051-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1052-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1053-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1054-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1055-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1056-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1057-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1058-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1059-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1060-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1061-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1062-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1063-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1064-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1065-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1066-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1067-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1068-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1069-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1070-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1071-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1072-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1073-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1074-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1075-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1076-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1077-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1078-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1079-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1080-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1081-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1082-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1083-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1084-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1085-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1086-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1087-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1088-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1089-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1090-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1091-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1092-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1093-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1094-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1095-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05

Product code LRP

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)