Z-1442-2024Class II
Centurion manual surgical kits labeled as: a) ST. VIRTUS SPLINTER FORCEP 6" (SF8246), Product Code 66580; b)...
MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-02-23 / Open, Classified / root cause: manufacturing process
MEDLINE INDUSTRIES, LP - Northfield began a recall of Centurion manual surgical kits labeled as: a) ST. VIRTUS SPLINTER FORCEP 6" (SF8246), Product Code 66580; b) DEBRIDEMENT TRAY, Product Code I86630; c) BIOPSY... 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-1442-2024
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Centurion manual surgical kits labeled as: a) ST. VIRTUS SPLINTER FORCEP 6" (SF8246), Product Code 66580; b) DEBRIDEMENT TRAY, Product Code I86630; c) BIOPSY INSTRUMENT PACK, Product Code I86690; d) DEBRIDEMENT TRAY, Product Code I86815; e) IR ADSON FORCEP & NEEDLE HOLDER, Product Code MNS12675; f) TOENAIL REMOVAL KIT, Product Code SUT20350 MEDLINE GENERAL PURPOSE INST. TRAY, Product Code DYNDA2346A
- Product code
- KDD Kit, Surgical Instrument, 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
- 7950 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Panama, Canada.
- Product codes and lots
- a) 66580, UDI/DI 10653160028963 (case) 00653160028966 (each), Lot Numbers: 2023041090; b) I86630, UDI/DI 00653160286540 (case) 10653160286547 (each), Lot Numbers: 2023101190; c) I86690, UDI/DI 00653160290752 (case) 10653160290759 (each), Lot Numbers: 2023103190; d) I86815, UDI/DI 00653160342291 (case) 10653160342298 (each), Lot Numbers: 2023112190; e) MNS12675, UDI/DI 00653160337341 (case) 10653160337348 (each), Lot Numbers: 2023070390; f) SUT20350, UDI/DI 00653160306552 (case) 10653160306559 (each), Lot Numbers: 2023022290, 2023041190, 2023042490, 2023052390, 2023101890 MEDLINE: UDI/DI 20193489191582 (case) 10193489191585 (each), Lot Numbers: 2023062290, 2023081490
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
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