FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Sterile.
- Recall number
- Z-1407-2023
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Sterile.
- Status
- Open, Classified
- Initiated
- 2023-03-02
- Posted
- 2023-04-19
- Terminated
- not on file
- Reason
- The CirClamp subassembly found in the kit was the incorrect size.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 162 units
- Distribution
- US Nationwide distribution in the states of CA and TX. There was no foreign/government/military distribution.
- Lot, serial or model codes
- Lot #2022070590, Exp. 2026-08-31, UDI (01)10653160312895(10)2022070590(17)260831.
- 510(k) numbers
- ["K890897"]
- PMA numbers
- not on file
- Product code
- HFX
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28