Z-1056-2020Class II

Centurion- SPEC0002B ARTHROGRAM TRAY SPEC0002B ARTHROGRAM TRAY SPEC0004C ARTHROGRAM TRAY SPEC0071B CUSTOM BX...

Name: Z-1056-2020 Centurion- SPEC0002B ARTHROGRAM TRAY SPEC0002B ARTHROGRAM TRAY SPEC0004C ARTHROGRAM TRAY SPEC0071B CUSTOM BX...
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- SPEC0002B ARTHROGRAM TRAY SPEC0002B ARTHROGRAM TRAY SPEC0004C ARTHROGRAM TRAY SPEC0071B CUSTOM BX TRAY SPEC0076G STEREO BIOPSY PACK-LF SPEC0122... 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-1056-2020
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- SPEC0002B ARTHROGRAM TRAY SPEC0002B ARTHROGRAM TRAY SPEC0004C ARTHROGRAM TRAY SPEC0071B CUSTOM BX TRAY SPEC0076G STEREO BIOPSY PACK-LF SPEC0122 BASIC BIOPSY TRAY SPEC0130B BREAST BIOPSY TRAY SPEC0158A CT BIOPSY TRAY SPEC0248B GENERAL BIOPSY TRAY- LF SPEC0265A 22G FACET TRAY SPEC0313 CYST ASPIRATION TRAY-LF SPEC0313 CYST ASPIRATION TRAY-LF
Product code: PXP Breast Biopsy / Localization Tray
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: SPEC0002B ARTHROGRAM TRAY 2019032090 SPEC0002B ARTHROGRAM TRAY 2019021890 SPEC0004C ARTHROGRAM TRAY 2019031290 SPEC0071B CUSTOM BX TRAY 2019022590 SPEC0076G STEREO BIOPSY PACK-LF 2019040590 SPEC0122 BASIC BIOPSY TRAY 2019011790 SPEC0130B BREAST BIOPSY TRAY 2019020590 SPEC0158A CT BIOPSY TRAY 2018122090 SPEC0248B GENERAL BIOPSY TRAY- LF 2019012990 SPEC0265A 22G FACET TRAY 2019010290 SPEC0313 CYST ASPIRATION TRAY-LF 2019061290 SPEC0313 CYST ASPIRATION TRAY-LF 2019021290

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1056-2020
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 PXP

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)