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Recall Observatory FDA recall evidence

Device product

Medline Convenience kits used for various procedures: 1) CW PERI GYN, Model Number: DYNJ80807B

Z-1612-2025

March 03, 2025

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 96510
Status
Ongoing
Classification
Class II
Quantity
48 units
Official record key
device-enforcement:Z-1612-2025

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) DYNJ80807B, UDI-DI: 10195327415624(each), 40195327415625(case), Lot Number: 24IBH993

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.