—#178560

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

FDA product code: LRP — Tray, Surgical
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot Numbers: DYNDH1033B SUBCLAVIAN ON/OFF KIT 2019061080 DYNDH1090A SDS PROCEDURE PACK 2019021990 DYNDH1110 BIOPSY PACK 2019032990 DYNDH1110 BIOPSY PACK 2019011590 DYNDH1110 BIOPSY PACK 2018092590 DYNDH1114 BIOPSY TRAY 2018111290 DYNDH1131 WDC ULTRASOUND KIT 2019030690 DYNDH1227A HOLSTON MYELOGRAM PACK 2019061090 DYNDH1227A HOLSTON MYELOGRAM PACK 2019022790 DYNDH1265 MYELOGRAM TRAY 2018101990 DYNDH1272 LUMBAR PUNCTURE TRAY 2019020590 DYNDH1281A PARA/THORA ULTRASOUND 2019040180 DYNDH1285A BIOPSY ULTRASOUND 2019051380 DYNDH1321 LUMBAR PUNCTURE TRAY 2019011590 DYNDH1349 ARTHROGRAM TRAY 2018121390 DYNDH1359 DIAGNOSTIC TRAY 2019040290 DYNDH1397 GENERAL ASPIRATION TRAY - CHOICE 2019031880 DYNDH1399 ARTHROGRAM TRAY 2019042290

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 #178560. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.