Medline Convenience kits used for various procedures: 1) T&A ENDO PACK, Model Number: DYNJ59620A; 2) TRAY ADD A CATH
Summary
The FDA issued a Class II for Medline Convenience kits used for various procedures: 1) T&A ENDO PACK, Model N by MEDLINE INDUSTRIES, LP - Northfield. Reason: There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits..
Details
Source
Device Recall
External ID
Z-1599-2025
Action Date
2025-04-23
Status
Ongoing
Category
device
Product Description
Medline Convenience kits used for various procedures: 1) T&A ENDO PACK, Model Number: DYNJ59620A; 2) TRAY ADD A CATH FOL UM MF 10ML, Model Number: DYND150200S
Lot/Code Info: 1) DYNJ59620A, UDI-DI: 10193489685367(each), 40193489685368(case), Lot Number: 24KBH321; 2) DYND150200S, UDI-DI: 10195327387884(each), 40195327387885(case), Lot Number: 24KBK308
Quantity Affected: 530 units
Reason for Recall
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-03-03
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 165 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-1599-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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