Recall Z-1056-2020— Centurion Medical Products Corporation
Class II · Terminated
Class II FDA medical device recall by Centurion Medical Products Corporation, initiated 2019-12-11, terminated 2020-09-04. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Incomplete seals on the sterile package may compromise the sterility.
- Recalling firm
- Centurion Medical Products Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-12-11
- Terminated
- 2020-09-04
- Firm location
- Williamston, MI, United States
Product description
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
Reason for recall
Incomplete seals on the sterile package may compromise the sterility
Data sourced from openFDA. This site is unofficial and independent of the FDA.