Recalls / —

—#174932

Product

EPISTAXIS TRAY Kit Code: MNS10165

FDA product code

OGR — Ear, Nose, And Throat Surgical Tray

Device class

Class 1

Medical specialty

Ear, Nose, Throat

Affected lot / code info

Lot # 2019051350 Exp 08/31/2020 Lot # 2019021501 Exp 04/30/2020 Lot # 2019010701 Exp 04/30/2020 Lot # 2018112601 Exp 04/30/2020 Lot # 2018092501 Exp 09/30/2019 Lot # 2018100201 Exp 09/30/2019 Lot # 2018062801 Exp 12/31/2019 Lot # 2018073101 Exp 09/30/2019 Lot # 2018042701 Exp 02/28/2019

Why it was recalled

Various medical device kits contain MAJOR Nasal Decongestant Spray is being recalled by the manufacturer

Root cause (FDA determination)

Material/Component Contamination

Action the firm took

1. Please identify all inventory that you have within your possession. Remove the MAJOR Nasal Decongestant from the mini-grip bag and segregate it in a location where it cannot be accessed for use. 2. 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 as directed. Upon receipt of this recall response, a Centurion Representative will contact you regarding retrieval of the product from your facility, if required. 3. please forward a copy of this notice to any facilities to whom this product may have been further distributed. If you have any questions, please contact (517) 546-5400 Ext 1122.

Recalling firm

Firm

Centurion Medical Products Corporation

Address

100 Centurion Way, Williamston, Michigan 48895-9086

Distribution

Distribution pattern

CT, IL

Timeline

Recall initiated

2019-06-24

Terminated

2020-07-24

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #174932. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.