Z-1439-2024Class II
Centurion Curette kits labeled as: a) STERILE BUCK EAR CURETTE "00" (25697), Product Code 66745; b) STERILE...
MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-02-23 / Open, Classified / root cause: manufacturing process
MEDLINE INDUSTRIES, LP - Northfield began a recall of Centurion Curette kits labeled as: a) STERILE BUCK EAR CURETTE "00" (25697), Product Code 66745; b) STERILE "1" EAR CURETTE (505629), Product Code 67050; c)... 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-1439-2024
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Centurion Curette kits labeled as: a) STERILE BUCK EAR CURETTE "00" (25697), Product Code 66745; b) STERILE "1" EAR CURETTE (505629), Product Code 67050; c) STERILE FOX DERMAL CURETTE, 5MM(32923), Product Code 67430; d) STERILE EXCAVATOR CURETTE (P/S), Product Code I67970; e) ST BUCK EAR CURETTE BLNT STR SZ 00, Product Code I68040; f) STERILE BRUNS CURETTE #4 (BC400S), Product Code I68340; g) 6MM FOX DERMAL CURETTE STERILE, Product Code I68380; h) STERILE KEVORKIAN CURETTE 4MM (KEC4S), Product Code I68470; i) ST ENDOCERVICAL BIOPSY CURETTE 2MM, Product Code I68480
- Product code
- HTF Curette
- 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
- 20614 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Panama, Canada.
- Product codes and lots
- a) 66745, UDI/DI 70653160060330 (case) 00653160060331 (each), Lot Numbers: 2023103090; b) 67050, UDI/DI 00653160357509 (case) 10653160357506 (each), Lot Numbers: 2023103090; c) 67430, UDI/DI 10653160123514 (case) 00653160123517 (each), Lot Numbers: 2023022190; d) I67970, UDI/DI 20653160224744 (case) 00653160224740 (each), Lot Numbers: 2023041390, 2023041490, 2023061990, 2023101290; e) I68040, UDI/DI 20653160228605 (case) 00653160228601 (each), Lot Numbers: 2023022190, 2023102090; f) I68340, UDI/DI 00653160279863 (case) 10653160279860 (each), Lot Numbers: 2023042490; g) I68380, UDI/DI 00653160284553 (case) 10653160284550 (each), Lot Numbers: 2023032790, 2023101790; h) I68470, UDI/DI 00653160290721 (case) 10653160290728 (each), Lot Numbers: 2023032190, 2023032390; i) I68480, UDI/DI 00653160292640 (case) 10653160292647 (each), Lot Numbers: 2023013190
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 |
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