—#178569

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

FDA product code: PXP — Breast Biopsy / Localization Tray
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: 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

Why it was recalled

Incomplete seals on the sterile package may compromise the sterility

Root cause (FDA determination)

Packaging process control

Action the firm took

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.

Recalling firm

Firm: Centurion Medical Products Corporation
Address: 100 Centurion Way, Williamston, Michigan 48895-9086

Distribution

Distribution pattern: Nationwide Foreign: GHANA

Timeline

Recall initiated: 2019-12-11
Terminated: 2020-09-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #178569. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.