Centurion Hemostat kits labeled as: a) STERILE CURV KELLY HEMOSTAT, Product Code 65340; b) STERILE CURV MOSQUITO HEM
Summary
The FDA issued a Class II for Centurion Hemostat kits labeled as: a) STERILE CURV KELLY HEMOSTAT, Product Co by MEDLINE INDUSTRIES, LP - Northfield. Reason: Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all u.
Details
Source
Device Recall
External ID
Z-1438-2024
Action Date
2024-04-10
Status
Ongoing
Category
device
Product Description
Centurion Hemostat kits labeled as: a) STERILE CURV KELLY HEMOSTAT, Product Code 65340; b) STERILE CURV MOSQUITO HEMOSTAT (MHS103), Product Code 66145; c) STERILE STRT KELLY HEMOSTAT (SK8039), Product Code 66170; d) STERILE CURV KELLY HEMOSTAT (CK8040), Product Code 66175; e) STERILE CURV SATIN HEMOSTAT (MHS103S), Product Code 66445; f) STERILE STRT SATIN HEMOSTAT (MHS102S), Product Code 66485; g) STERILE STRT KELLY HEMOSTAT (SK8039S), Product Code 66695; h) STERILE STRAIGHT KELLY HEMOSTAT, Product Code 67140; i) ST. STR MOSQUITO HEMOSTAT 3 1/2"(MHB700), Product Code 67325; j) STERILE CVD MOSQT HEMOST 3 1/2"(MHB710), Product Code 67330; k) STERILE 8" CRVD KELLY HEMOSTAT (CK1008), Product Code 67655; l) STERILE 8" STR KELLY HEMOSTAT (SK1008), Product Code 67660; m) ST MOSQUITO HEMO CURVED FINE PT (P/S), Product Code I68100; n) ST CURVED KELLY HEMOSTAT-TAMPA GEN, Product Code I68310; o) STERILE STRT KELLY HEMOSTAT (ZM-09417), Product Code P-65240; p) STERILE STRT MOSQUITO HEMOSTAT (MHS102), Product Code TRI66140; q) STERILE CURVED KELLY HEMO (ST153), Product Code TRI66765
Lot/Code Info: a) 65340, UDI/DI 10653160038023 (case) 00653160038026 (each), Lot Numbers: 2023041090, 2023061290, 2023091190; b) 66145, UDI/DI 70653160008783 (case) 00653160008784 (each), Lot Numbers: 2023042690, 2023042790, 2023072790; c) 66170, UDI/DI 70653160024035 (case) 00653160024036 (each), Lot Numbers: 2023031090, 2023041790; d) 66175, UDI/DI 60653160039575 (case) 00653160039573 (each), Lot Numbers: 2023031390, 2023050990, 2023082490, 2023103090; e) 66445, UDI/DI 70653160023779 (case) 00653160023770 (each), Lot Numbers: 2023070390, 2023071090; f) 66485, UDI/DI 60653160029200 (case) 00653160029208 (each), Lot Numbers: 2023042690, 2023090790; g) 66695, UDI/DI 60653160024861 (case) 00653160024869 (each), Lot Numbers: 2023042790; h) 67140, UDI/DI 60653160049871 (case) 00653160049879 (each), Lot Numbers: 2023112990; i) 67325, UDI/DI 10653160110675 (case) 00653160110678 (each), Lot Numbers: 2023042490; j) 67330, UDI/DI 30653160110730 (case) 00653160110739 (each), Lot Numbers: 2023042890; k) 67655, UDI/DI 10653160196006 (case) 00653160196009 (each), Lot Numbers: 2023030290; l) 67660, UDI/DI 10653160196013 (case) 00653160196016 (each), Lot Numbers: 2023031390, 2023101990; m) I68100, UDI/DI 10653160235811 (case) 00653160235814 (each), Lot Numbers: 2023041190, 2023060790; n) I68310, UDI/DI 00653160278835 (case) 10653160278832 (each), Lot Numbers: 2023022190; o) P-65240, UDI/DI 10653160359234 (case) 20653160359231 (each), Lot Numbers: 2023120590; p) TRI66140, UDI/DI 00653160317855 (case) 10653160317852 (each), Lot Numbers: 2023032890, 2023061690; q) TRI66765, UDI/DI 00653160317947 (case) 10653160317944 (each), Lot Numbers: 2023030990
Quantity Affected: 80903 units
Reason for Recall
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
Distribution
Worldwide distribution - US Nationwide and the countries of Panama, Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-02-23
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 200 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-1438-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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