Z-1427-2024Class II
Centurion STERILE TRACH BRUSH, Product Code 6225ST
MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-02-23 / Open, Classified / root cause: manufacturing process
MEDLINE INDUSTRIES, LP - Northfield began a recall of Centurion STERILE TRACH BRUSH, Product Code 6225ST on . FDA classified it as Class II and gives the reason as "Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1427-2024
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Centurion STERILE TRACH BRUSH, Product Code 6225ST
- Product code
- EPE Brush, Cleaning, Tracheal Tube
- Reason for recall
- Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- Root cause tag
- manufacturing process
- FDA root cause
- Process control
- Action
- Medline Industries, LP, issued a Medical Device Recall notice to its consignees on 02/27/2024 via email and USPS First Class mail. The notice explained the problem with the devices, risk, and requested that the products be destroyed at the consignee. Distributors were directed to notify their customers.
- Quantity in commerce
- 1700
- Distribution
- Worldwide distribution - US Nationwide and the countries of Panama, Canada.
- Product codes and lots
- UDI/DI 50653160004750 (case), 00653160004755 (each), Lot Numbers: 2023021090
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1427-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1428-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1429-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1430-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1431-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1432-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1433-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1434-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1435-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1436-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1437-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1438-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1439-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1440-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1441-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1442-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1443-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1444-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1445-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1446-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1447-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1448-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1449-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1450-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1451-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1452-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1453-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1454-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1455-2024 | Class II | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.