Centurion CirClamp with 1.3cm Bell & Insert Reprocessed… recallZ-1407-2023 · MEDLINE INDUSTRIES, LP - Northfield · initiated Mar 2, 2023
Class II Open, Classified All recalls posted in April 2023
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The CirClamp subassembly found in the kit was the incorrect size.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1407-2023
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Mar 2, 2023
- Posted by the FDA
- Apr 19, 2023
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 162 units
- Product code
- HFX
- FDA submissions
- K890897
- Distribution
- US Nationwide distribution in the states of CA and TX. There was no foreign/government/military distribution.
Product description
Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Sterile.
Code information (models, lots, serial numbers)
Lot #2022070590, Exp. 2026-08-31, UDI (01)10653160312895(10)2022070590(17)260831.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Centurion CR230KCenturion Medical Products Corporation · CLAMP, CIRCUMCISION2 recalls0 reports
Other devices under the same FDA submission
14 devices cleared under K890897 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Centurion CR3145KCenturion Medical Products Corporation · CLAMP, CIRCUMCISION2 recalls0 reports
- Centurion 330CRKCenturion Medical Products Corporation · CLAMP, CIRCUMCISION1 recall8 reports
- Centurion 310CRCenturion Medical Products Corporation · CLAMP, CIRCUMCISION1 recall4 reports
- Centurion 330CRCenturion Medical Products Corporation · CLAMP, CIRCUMCISION1 recall1 report
- Centurion 210CRCenturion Medical Products Corporation · CLAMP, CIRCUMCISION1 recall0 reports
- Centurion 230CRCenturion Medical Products Corporation · CLAMP, CIRCUMCISION1 recall0 reports
- Centurion 245CRCenturion Medical Products Corporation · CLAMP, CIRCUMCISION1 recall0 reports
- Centurion 3145CRCenturion Medical Products Corporation · CLAMP, CIRCUMCISION1 recall0 reports
- Centurion 345CRCenturion Medical Products Corporation · CLAMP, CIRCUMCISION1 recall0 reports
- Centurion 200CRCenturion Medical Products Corporation · CLAMP, CIRCUMCISION1 recall0 reports
- Centurion 310CRKCenturion Medical Products Corporation · CLAMP, CIRCUMCISION1 recall0 reports
- Centurion CR245KCenturion Medical Products Corporation · CLAMP, CIRCUMCISION1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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