—#178526

Product

Centurion Chest Tube Trays: Kit Code Product CHT1170 CHEST TUBE TRAY CHT1700 CHEST TUBE INSERTION TRAY CHT1760 CHEST TRAY CHT275 CHEST TUBE INSERTION TRAY CHT440 CHEST TUBE INSERTION TRAY CHT701 CHEST TUBE INSERTION TRAY CHT760 CHEST TUBE INSERTION TRAY CHT940 CHEST TUBE INSERTION TRAY

FDA product code: PYI — Thoracic Catheter Insertion Tray
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Kit Code Product Lot Number CHT1170 CHEST TUBE TRAY 2019011690 CHT1700 CHEST TUBE INSERTION TRAY 2018111490 CHT1760 CHEST TRAY 2019031490 CHT275 CHEST TUBE INSERTION TRAY 2019050890 CHT440 CHEST TUBE INSERTION TRAY 2019050690 CHT701 CHEST TUBE INSERTION TRAY 2019012590 CHT760 CHEST TUBE INSERTION TRAY 2018110890 CHT940 CHEST TUBE INSERTION TRAY 2019010290

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 #178526. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.