(1) Centurion Sterile CirClamp, Reorder #200CR; (2) Centurion CirClamp with 1.1cm Bell and Insert, Reorder #210CR, Ster
Summary
The FDA issued a Class II for (1) Centurion Sterile CirClamp, Reorder #200CR; (2) Centurion CirClamp with 1.1 by MEDLINE INDUSTRIES, LP - Northfield. Reason: Product has been identified as having holes in the packaging..
Details
Source
Device Recall
External ID
Z-0133-2025
Action Date
2024-10-30
Status
Ongoing
Category
device
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.
Lot/Code Info: (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.
Quantity Affected: 498,354 kits
Reason for Recall
Product has been identified as having holes in the packaging.
Distribution
Worldwide distribution - US Nationwide and the countries of India and Panama.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-09-03
Company
Northfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 253 device recalls issued in the same week, part of 413 device-related FDA actions this month.
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MEDLINE INDUSTRIES, LP - Northfield) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MEDLINE INDUSTRIES, LP - Northfield have FDA actions?
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0133-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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