Z-0133-2025 Class II Ongoing

Recalled by MEDLINE INDUSTRIES, LP - Northfield — Northfield, IL

Recall Details

Product Type
Devices
Report Date
October 30, 2024
Initiation Date
September 3, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
498,354 kits

Product Description

(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.

Reason for Recall

Product has been identified as having holes in the packaging.

Distribution Pattern

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

Code Information

(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.