Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ57622; 2) C SECTION PACK, Pack Number DYNJ48483B;
Summary
The FDA issued a Class II for Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ57622; 2) by MEDLINE INDUSTRIES, LP - Northfield. Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues.
Details
Source
Device Recall
External ID
Z-1448-2025
Action Date
2025-04-02
Status
Ongoing
Category
device
Product Description
Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ57622; 2) C SECTION PACK, Pack Number DYNJ48483B; 3) C SECTION PACK, Pack Number DYNJ61573; 4) C SECTION PACK, Pack Number DYNJ66801; 5) C SECTION PACK-LF, Pack Number DYNJ0367951P; 6) C SECTION PACK-LF, Pack Number DYNJ55345D; 7) C-SECTION PACK, Pack Number DYNJ04521J; 8) C-SECTION PACK, Pack Number DYNJ32632F; 9) C-SECTION PACK, Pack Number DYNJ65961B; 10) SMJ C-SECTION PACK-LF, Pack Number DYNJ38582J
Lot/Code Info: 1) Pack Number DYNJ57622: UDI/DI 10889942757244 (each) 40889942757245 (case), Lot Number 20LMF902A; 2) Pack Number DYNJ48483B: UDI/DI 10193489659405 (each) 40193489659406 (case), Lot Number 20CKB746A; 3) Pack Number DYNJ61573: UDI/DI 10193489601077 (each) 40193489601078 (case), Lot Number 22CMB584A; 4) Pack Number DYNJ66801: UDI/DI 10193489384000 (each) 40193489384001 (case), Lot Number 22GBW063A; 5) Pack Number DYNJ0367951P: UDI/DI 10193489966923 (each) 40193489966924 (case), Lot Number 21IMH644A; 6) Pack Number DYNJ55345D: UDI/DI 10195327173722 (each) 40195327173723 (case), Lot Number 22GBJ830A; 7) Pack Number DYNJ04521J: UDI/DI 10193489555837 (each) 40193489555838 (case), Lot Number 21HMA851A; 8) Pack Number DYNJ32632F: UDI/DI 10193489888966 (each) 40193489888967 (case), Lot Number 21IMD959A; 9) Pack Number DYNJ65961B: UDI/DI 10193489984309 (each) 40193489984300 (case), Lot Number 23LMG679A; 10) Pack Number DYNJ38582J: UDI/DI 10193489528244 (each) 40193489528245 (case), Lot Number 21IMF094A
Quantity Affected: 605 units
Reason for Recall
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-02-11
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 216 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-1448-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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