Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0409-2020Class II

NOSEBLEED TRAY Kit Code: MNS3885

Centurion Medical Products, LP / initiated 2019-06-24 / Terminated / root cause: manufacturing process

Centurion Medical Products Corporation began a recall of NOSEBLEED TRAY Kit Code: MNS3885 on . FDA classified it as Class II and gives the reason as "Various medical device kits contain MAJOR Nasal Decongestant Spray is being recalled by the manufacturer". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0409-2020
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Centurion Medical Products, LP
Product
NOSEBLEED TRAY Kit Code: MNS3885
Product code
OGR Ear, Nose, And Throat Surgical Tray
Reason for recall
Various medical device kits contain MAJOR Nasal Decongestant Spray is being recalled by the manufacturer.
Root cause tag
manufacturing process
FDA root cause
Material/Component Contamination
Action
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.
Quantity in commerce
30 Kits
Distribution
CT, IL
Product codes and lots
Lot # 2018121780 Exp 08/31/2020 Lot # 2018111280 Exp 05/31/2020

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0409-2020
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0407-2020Class IITerminatedVoluntary: Firm initiated
Z-0408-2020Class IITerminatedVoluntary: Firm initiated
Z-0409-2020Class IITerminatedVoluntary: Firm initiated