Z-0408-2020Class II

YNHH SCOPE KIT Kit Code: MNS10475

Name: Z-0408-2020 YNHH SCOPE KIT Kit Code: MNS10475
Creator: Centurion Medical Products Corporation
Published: 2019-06-24
License: https://open.fda.gov/license/

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

FDA source

Centurion Medical Products Corporation began a recall of YNHH SCOPE KIT Kit Code: MNS10475 on 2019-06-24. 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 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0408-2020
Classification: Class II
Status: Terminated
Initiated: 2019-06-24
Posted: 2019-11-15
Terminated: 2020-07-24
Recalling firm: Centurion Medical Products, LP
Product: YNHH SCOPE KIT Kit Code: MNS10475
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: 644 Kits
Distribution: CT, IL
Product codes and lots: Lot # 2019060750 Exp 08/31/2020 Lot # 2019060450 Exp 08/31/2020 Lot # 2018110550 Exp 05/31/2020

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0408-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0407-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-27	2019-11-15
Z-0408-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-27	2019-11-15
Z-0409-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-27	2019-11-15

Product code OGR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)