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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0407-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0408-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0409-2020 | Class II | Terminated | Voluntary: Firm initiated |
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