Z-1095-2020Class II

Centurion- P151659 BIOPSY TRAY P243133 LATEX TUBING PACK P243133 LATEX TUBING PACK P243133 LATEX TUBING PACK...

Name: Z-1095-2020 Centurion- P151659 BIOPSY TRAY P243133 LATEX TUBING PACK P243133 LATEX TUBING PACK P243133 LATEX TUBING PACK...
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- P151659 BIOPSY TRAY P243133 LATEX TUBING PACK P243133 LATEX TUBING PACK P243133 LATEX TUBING PACK P261569 PACK BIOPSY P392929 BMT-LACERATION PACK... 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-1095-2020
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- P151659 BIOPSY TRAY P243133 LATEX TUBING PACK P243133 LATEX TUBING PACK P243133 LATEX TUBING PACK P261569 PACK BIOPSY P392929 BMT-LACERATION PACK P429589A TRAY BONE MARRO ASC LTX SAFE P734457 SUTURE REMOVAL PACK LATEX SAFE P751651A BIOPSY PROCEDURE PACK P758486 PVP PREP PACK P758486 PVP PREP PACK P922260 ALCOHOL PREP PACK P928310 WET PREP TRAY P928310 WET PREP TRAY P948416 LACERATION PACK P966455A BREAST BIOPSY PACK-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: Product/Lot Number: P151659 BIOPSY TRAY 2019031490 P243133 LATEX TUBING PACK 2019042590 P243133 LATEX TUBING PACK 2019031990 P243133 LATEX TUBING PACK 2019022190 P261569 PACK BIOPSY 2019021490 P392929 BMT-LACERATION PACK 2018121790 P429589A TRAY BONE MARRO ASC LTX SAFE 2019012590 P734457 SUTURE REMOVAL PACK LATEX SAFE 2019031990 P751651A BIOPSY PROCEDURE PACK 2019020890 P758486 PVP PREP PACK 2019041590 P758486 PVP PREP PACK 2019031990 P922260 ALCOHOL PREP PACK 2019041580 P928310 WET PREP TRAY 2019050690 P928310 WET PREP TRAY 2019031590 P948416 LACERATION PACK 2018110990 P966455A BREAST BIOPSY PACK-LF 2018122790

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1095-2020
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)