Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Sterile.
FDA device recall Z-1407-2023 · posted 2023-04-19 · Open, Classified
Recall details
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Reason for recall
- The CirClamp subassembly found in the kit was the incorrect size.
- Action taken
- The recalling firm issued letters dated 3/2/2023 via first class mail informing the consignee of the issue and to remove it from stock and dispose of it. The letter provided required actions which again included destroying the affected product and to return the completed enclosed destruction form listing the quantity of affected product destroyed. Once the destruction form is received, the account will be issued a credit. If the device has been transferred to another individual, department or location, the consignee is to notify them of this recall communication.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- HFX
- Quantity affected
- 162 units
- Distribution
- US Nationwide distribution in the states of CA and TX. There was no foreign/government/military distribution.
- Date initiated
- 2023-03-02
- Date posted
- 2023-04-19
- Location
- Northfield, IL
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CENTURION CIRCLAMP (K890897) | Tri-State Hospital Supply Corp. | 1989-03-28 |