Z-1440-2024Class II
Centurion Clamp kits labeled as: a) STERILE BACKHAUS TOWEL CLAMP (BTC173), Product Code 66520; 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 Clamp kits labeled as: a) STERILE BACKHAUS TOWEL CLAMP (BTC173), Product Code 66520; b) STERILE TOWEL CLAMP, Product Code A547ST; c) ST TOWEL CLAMPS... 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-1440-2024
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Centurion Clamp kits labeled as: a) STERILE BACKHAUS TOWEL CLAMP (BTC173), Product Code 66520; b) STERILE TOWEL CLAMP, Product Code A547ST; c) ST TOWEL CLAMPS NON PERFORATING (P/S), Product Code I68080; d) STERILE TOWEL CLAMPS 5 1/2, Product Code I68085; e) STERILE TOWEL CLAMPS 5 1/2", Product Code I68095; f) ZIPSER PENIS CLAMP STERILE (ZC110), Product Code ZC110ST
- Product code
- HXD Clamp
- 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
- 12980 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Panama, Canada.
- Product codes and lots
- a) 66520, UDI/DI 60653160040960 (case) 00653160040968 (each), Lot Numbers: 2023111590; b) A547ST, UDI/DI 10653160113683 (case) 00653160113686 (each), Lot Numbers: 2023020990, 2023033090, 2023060790, 2023092990; c) I68080, UDI/DI 20653160232602 (case) 00653160232608 (each), Lot Numbers: 2023072790; d) I68085, UDI/DI 30653160232616 (case) 00653160232615 (each), Lot Numbers: 2023032290, 2023071790; e) I68095, UDI/DI 20653160232695 (case) 00653160232691 (each), Lot Numbers: 2023062690; f) ZC110ST, UDI/DI 00653160258462 (case) 10653160258469 (each), Lot Numbers: 2023022490, 2023041090, 2023052290, 2023062890
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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