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Recall Observatory FDA recall evidence

Device product

Medline Convenience kits used for various procedures: 1) HERNIA REPAIR TOTE, Model Number: DYNJ908337C

Z-1609-2025

March 03, 2025

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 96510
Status
Ongoing
Classification
Class II
Quantity
40 units
Official record key
device-enforcement:Z-1609-2025

Official wording

Reason: There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Code information: 1) DYNJ908337C, UDI-DI: 10198459085925(each), 40198459085926(case), Lot Number: 24KBK455

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.