Centurion Manual surgical kits labeled as: a) STERILE S/B WIRE SCISSOR, Product Code 65140; b) SHARP/SHARP...
MEDLINE INDUSTRIES, LP - Northfield began a recall of Centurion Manual surgical kits labeled as: a) STERILE S/B WIRE SCISSOR, Product Code 65140; b) SHARP/SHARP SCISSORS 41/2", Product Code 65840; c) STERILE WIRE... 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-1449-2024
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Centurion Manual surgical kits labeled as: a) STERILE S/B WIRE SCISSOR, Product Code 65140; b) SHARP/SHARP SCISSORS 41/2", Product Code 65840; c) STERILE WIRE CUTTER (WCS144), Product Code 66240; d) STERILE LISTER BANDAGE SCISSOR (LS122), Product Code 66855; e) STERILE UTILITY SHEARS (USH176), Product Code 67225; f) STERILE ANGLED BANDAGE SCISSOR (LIST55), Product Code TRI66670
- Product code
- JOK Scissors, Medical, Disposable
- 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
- 84224 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Panama, Canada.
- Product codes and lots
- a) 65140, UDI/DI 60653160008380 (case) 00653160008388 (each), Lot Numbers: 2023060790, 2023101090; b) 65840, UDI/DI 60653160010208 (case) 00653160010206 (each), Lot Numbers: 2023022790, 2023041190; c) 66240, UDI/DI 60653160008793 (case) 00653160008791 (each), Lot Numbers: 2023112790; d) 66855, UDI/DI 50653160007188 (case) 00653160007183 (each), Lot Numbers: 2023022490, 2023041990, 2023102690; e) 67225, UDI/DI 50653160001766 (case) 00653160001761 (each), Lot Numbers: 2023031690, 2023111490; f) TRI66670, UDI/DI 10653160317975 (case) 20653160317972 (each), Lot Numbers: 2023031490, 2023040690, 2023041090, 2023062790, 2023062890, 2023072490, 2023101690, 2023110190, 2023110990
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.
