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Open, Classified

(1) Centurion Sterile CirClamp, Reorder #200CR; (2) Centurion CirClamp with 1.1cm Bell and Insert, Reorder #210CR, Sterile; (3) Centurion CirClamp with 1.13cm Bell and Insert, Reorder #230CR, Sterile; (4) Centurion CirClamp with 1.45cm Bell and Insert, Reorder #245CR, Sterile; (5) Centurion CirClamp with 1.1cm Bell, Reorder #310CR, Sterile; (6) Centurion CirClamp with 1.1cm Bell Reprocessed, Reorder #310CRK, Sterile; (7) Centurion CirClamp with 1.3cm Bell, Reorder #330CR, Sterile; (8) Centurion CirClamp with 1.3cm Bell Reprocessed, Reorder #330CRK, Sterile; (9) Centurion CirClamp with 1.6cm Bell, Reorder #345CR, Sterile; (10) Centurion CirClamp with 1.45cm Bell, Reorder #3145CR, Sterile; (11) Centurion CirClamp with 1.1cm Bell & Insert Reprocessed, Reorder #CR210K, Sterile; (12) Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Sterile; (13) Centurion CirClamp with 1.145cm Bell & Insert Reprocessed, Reorder #CR245K, Sterile; (14) Centurion CirClamp with 1.6cm Bell Reprocessed, Reorder #CR345K, Sterile; and (15) Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder #CR3145K.

FDA Recall Z-0133-2025 · Posted 2024-10-18

Recalling FirmMEDLINE INDUSTRIES, LP - Northfield
Recall StatusOpen, Classified
Product CodeHFX
Date Initiated2024-09-03
Product Quantity498,354 kits

Reason for Recall

Product has been identified as having holes in the packaging.

Firm Action

The recalling firm issued letters on and dated 9/3/2024 via first class mail or email. The letter explained the reason for recall and the required action, which included: (1) Immediately check your stock for the affected item and lot numbers which can be located within the recall portal and quarantine all affected product immediately; (2) Use the link and information in the letter to complete the response form to list the quantity of affected product in inventory; (3) Upon receipt of the response form, return labels will be provided; (4) If you are a distributor or have resold or transferred the product to another company or individual, the distributor is to notify them of this recall communication. The firm included a spreadsheet with the communication that listed the items and lot numbers.

Root Cause

Device Design

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of India and Panama.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K890897CENTURION CIRCLAMPTri-State Hospital Supply Corp. · 1989-03-28

Official Source

View FDA Recall →

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

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