Recalls / —

—#178907

Product

Centurion-Skin Prep Trays SP1180 DRY PREP SET SP200 SKIN SCRUB TRAY SP415 STERILE GAUZE SPONGE

FDA product code

OJU — Skin Prep Tray

Device class

Class 1

Medical specialty

General, Plastic Surgery

Affected lot / code info

Product/Description/Lot Numbers: SP1180 DRY PREP SET 2019032690 SP200 SKIN SCRUB TRAY 2019051390 SP415 STERILE GAUZE SPONGE 2019011090, 2018120390

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 #178907. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.