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Recall Observatory FDA recall evidence

Device 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.

Z-0133-2025

September 03, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 95337
Status
Ongoing
Classification
Class II
Quantity
498,354 kits
Official record key
device-enforcement:Z-0133-2025

Official wording

Reason: Product has been identified as having holes in the packaging.

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.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product has been identified as having holes in the packaging.