MEDLINE INDUSTRIES, LP - Northfield: (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.

Recall number

Z-0133-2025

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield

Product

(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.

Status

Open, Classified

Initiated

2024-09-03

Posted

2024-10-18

Terminated

not on file

Reason

Product has been identified as having holes in the packaging.

Root cause

Device Design

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.

Quantity

498,354 kits

Distribution

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

Lot, serial or model codes

(1) Reorder #200CR - lot numbers 2021100190, 2021121390, 2022012090, and 2023071801; UDI-DI each - 10653160278139; UDI-DI case - 10653160278139; (2)Reorder #210CR - lot numbers 2022081901, 2023071901, 2023091101, 2023110801, and 2024012901; UDI-DI each - 00653160197440; UDI-DI case - 10653160197447; (3) Reorder #230CR - lot numbers 2021100190, 2021121690, 2023071801, 2023090501, 2023103001, 2023111301, 2023112101, 2024010301, 2024012401, and 2024020190; UDI-DI each - 00653160197457; UDI-DI case - 10653160197454; (4) Reorder #245CR - lot numbers 2021102590, 2023071901, 2023083001, 2023100401, 2023101201, 2023103001, 2023111001, 2023112101, 2024011701, 2024030501, and 2024041801; UDI-DI each - 00653160197464; UDI-DI case - 10653160197461; (5) Reorder #310CR - lot numbers 2021100590, 2021101190, 2022050401, 2022050601, 2022081201, 2022112801, 2022120101, 2023012401, 2023031501, 2023032101, 2023040601, 2023040701, 2023041201, 2023041401, 2023041701, 2023042101, 2023042401, 2023042501, 2023042701, 2023042801, 2023050401, 2023050501, 2023050901, 2023051801, 2023112001, 2023121101, 2023121901, 2023122901, 2024010801, 2024011001, 2024012590, 2024021201, 2024022001, 2024022701, 2024030401, 2024030601, 2024031101, 2024031501, 2024031801, 2024032101, 2024032601, 2024040301, 2024041001, 2024041201, and 2024042201; UDI-DI each - 00653160197471; UDI-DI case - 10653160197478; (6) Reorder #310CRK - lot numbers 2021092490, 2021092990, 2021101190, 2021102890, 2021110590, 2021120690, 2021120990, 2021122090, 2021122790, 2022010590, 2022011090, 2022020390, 2022022201, 2022030290, 2022030101, 2022030401, 2022031601, 2022032301, 2022032501, 2022032901, 2022040101, 2022040501, 2022041201, 2022042001, 2022042201, 2022052701, 2022062201, 2022062901, 2022080201, 2022081601, 2022090201, 2022090801, 2022092701, 2022101001, 2022111401, 2022111801, 2022120601, 2023010301, 2023010901, 2023020201, 2023021001, 2023021501, 2023022001, 2023022101, 2023022701, 2023031401, 2023031601, 2023032001, 2023032301, 2023032801, 2023033001, 2023040401, 2023051801, 2023052301, 2023052501, 2023053001, 2023053101, 2023081501, 2023101801, 2023111001, 2023120701, 2023121801, 2024010401, 2024011801, 2024022701, 2024032801, and 2024041601; UDI-DI each - 10653160309895; UDI-DI case - 00653160309898; (7) Reorder #330CR - lot numbers 2021102590, 2022120701, 2022120901, 2023012701, 2023013001, 2023052201, 2023072701, 2023081501, 2023111401, 2024010301, 2024030701, 2024031301, 2024031901, 2024032801, 2024032901, and 2024041001; UDI-DI each - 00653160197495; UDI-DI case - 10653160197492; (8) Reorder #330CRK - lot numbers 2021092490, 2021092990, 2021101190, 2021102690, 2021110890, 2021112990, 2021120690, 2021121590, 2021122090, 2022010590, 2022011090, 2022012090, 2022020390, 2022021890, 2022022101, 2022022801, 2022030290, 2022030301, 2022030701, 2022031701, 2022032301, 2022041801, 2022042101, 2022042501, 2022062701, 2022070101, 2022091201, 2022092101, 2022101301, 2022101701, 2022102801, 2022110901, 2022121401, 2022121901, 2023010901, 2023011101, 2023011701, 2023012001, 2023020601, 2023021701, 2023022401, 2023030601, 2023030901, 2023031001, 2023032101, 2023032301, 2023033001, 2023040301, 2023041301, 2023041801, 2023041901, 2023050201, 2023051501, 2023053101, 2023060701, 2023061201, 2023061401, 2023061601, 2023062001, 2023062301, 2023062701, 2023062901, 2023071001, 2023082201, 2023082501, 2023090701, 2023091901, 2023092501, 2023101601, 2024011501, 2024011801, 2024012401, 2024012690, 2024020201, 2024020890, 2024020601, 2024020801, 2024022890, 2024031201, 2024031801, and 2024041801; UDI-DI each - 10653160309901; UDI-DI case - 00653160309904; (9) Reorder #345CR - lot numbers 2023083001 and 2023122001; UDI-DI each - 00653160197501; UDI-DI case - 10653160197508; (10) Reorder #3145CR - lot numbers 2021102590, 2022092701, 2022111701, 2022112901, 2023061401, 2023062101, 2023083101, 2024013101, 2024022890, 2024030101, and 2024042201; UDI-DI each - 00653160197488; UDI-DI case - 10653160197485; (11) Reorder #210K - lot numbers 2021102590, 2021111890, 2022012490, 2022101901, 2022110801, 2022122101, 2023052301, 2023071201, 2023081001, 2023083001, 2023111301, 2024010801, and 2024012690; UDI-DI each 10653160312932; UDI-DI case - 00653160312935; (12) Reorder #230K - lot numbers 2022070590, 2022081590, 2022090990, 2022110401, 2022110890; UDI-DI each - 10653160312895; UDI-DI case - 00653160312898; (13) Reorder #245K - lot numbers 2021102590, 2022022490, 2022031490, 2022033001, 2022080501, 2022082201, 2022100501, 2022102801, and 2022110401; UDI-DI each - 10653160312901; UDI-DI case - 00653160312904; (14) Reorder #345K - lot numbers 2022012090, 2022072190, 2022082290, 2022090690, 2022110301, 2022122201, and 2023030201;, UDI-DI each 10653160312949; UDI-DI case - 00653160312942; and (15) Reorder #3145K - lot numbers 2021122090, 2021122190, 2022022190, 2022030790, 2022031701, 2022032501, 2022033101, 2022041201, 2022051001, 2022052401, 2022052701, 2022080501, 2022081801, 2022100401, 2022102601, 2022112901, 2023011101, 2023062101, 2023081501, and 2024012901; UDI-DI each - 10653160312956; UDI-DI case - 00653160312959.

510(k) numbers

["K890897"]

PMA numbers

not on file

Product code

HFX

Firm FEI

1417592

Firm city

Northfield

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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