FDA Medical Device Recalls (openFDA)
Centurion Medical Products Corporation: 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
- Recall number
- Z-1056-2020
- Recalling firm
- Centurion Medical Products Corporation
- 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
- Status
- Terminated
- Initiated
- 2019-12-11
- Posted
- not on file
- Terminated
- 2020-09-04
- Reason
- Incomplete seals on the sterile package may compromise the sterility
- 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.
- Quantity
- not on file
- Distribution
- Nationwide Foreign: GHANA
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- PXP
- Firm FEI
- 3008403546
- Firm city
- Williamston
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28