Z-1407-2023Class II

Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Sterile

Name: Z-1407-2023 Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Sterile
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2023-03-02
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2023-03-02 / Open, Classified

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Sterile on 2023-03-02. FDA classified it as Class II and gives the reason as "The CirClamp subassembly found in the kit was the incorrect size". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1407-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-03-02
Posted: 2023-04-19
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Sterile.
Product code: HFX Clamp, Circumcision
Reason for recall: The CirClamp subassembly found in the kit was the incorrect size.
FDA 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 in commerce: 162 units
Distribution: US Nationwide distribution in the states of CA and TX. There was no foreign/government/military distribution.
Product codes and lots: Lot #2022070590, Exp. 2026-08-31, UDI (01)10653160312895(10)2022070590(17)260831.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1407-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1407-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-26	2023-04-19

Product code HFX

K890897Class IICenturion CirclampTri-State Hospital Supply Corp. / cleared 1989-03-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)