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Open, Classified

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

FDA Recall Z-1407-2023 · Posted 2023-04-19

Recall StatusOpen, Classified
Product CodeHFX
Date Initiated2023-03-02
Product Quantity162 units

Reason for Recall

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

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.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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