Recall Z-1052-2020— 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-General Surgery Convenience Kits DYNDH1033B SUBCLAVIAN ON/OFF KIT DYNDH1090A SDS PROCEDURE PACK DYNDH1110 BIOPSY PACK DYNDH1110 BIOPSY PACK DYNDH1110 BIOPSY PACK DYNDH1114 BIOPSY TRAY DYNDH1131 WDC ULTRASOUND KIT DYNDH1227A HOLSTON MYELOGRAM PACK DYNDH1227A HOLSTON MYELOGRAM PACK DYNDH1265 MYELOGRAM TRAY DYNDH1272 LUMBAR PUNCTURE TRAY DYNDH1281A PARA/THORA ULTRASOUND DYNDH1285A BIOPSY ULTRASOUND DYNDH1321 LUMBAR PUNCTURE TRAY DYNDH1349 ARTHROGRAM TRAY DYNDH1359 DIAGNOSTIC TRAY DYNDH1397 GENERAL ASPIRATION TRAY - CHOICE DYNDH1399 ARTHROGRAM TRAY. 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-General Surgery Convenience Kits DYNDH1033B SUBCLAVIAN ON/OFF KIT DYNDH1090A SDS PROCEDURE PACK DYNDH1110 BIOPSY PACK DYNDH1110 BIOPSY PACK DYNDH1110 BIOPSY PACK DYNDH1114 BIOPSY TRAY DYNDH1131 WDC ULTRASOUND KIT DYNDH1227A HOLSTON MYELOGRAM PACK DYNDH1227A HOLSTON MYELOGRAM PACK DYNDH1265 MYELOGRAM TRAY DYNDH1272 LUMBAR PUNCTURE TRAY DYNDH1281A PARA/THORA ULTRASOUND DYNDH1285A BIOPSY ULTRASOUND DYNDH1321 LUMBAR PUNCTURE TRAY DYNDH1349 ARTHROGRAM TRAY DYNDH1359 DIAGNOSTIC TRAY DYNDH1397 GENERAL ASPIRATION TRAY - CHOICE DYNDH1399 ARTHROGRAM TRAY
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.