Recalls / —

—#199141

Product

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

FDA product code

HFX — Clamp, Circumcision

Device class

Class 2

Medical specialty

Obstetrics/Gynecology

510(k) numbers

K890897

Affected lot / code info

Lot #2022070590, Exp. 2026-08-31, UDI (01)10653160312895(10)2022070590(17)260831.

Why it was recalled

The CirClamp subassembly found in the kit was the incorrect size.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm

MEDLINE INDUSTRIES, LP Northfield

Address

3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern

US Nationwide distribution in the states of CA and TX. There was no foreign/government/military distribution.

Timeline

Recall initiated

2023-03-02

Posted by FDA

2023-04-19

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #199141. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.