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Recall Observatory FDA recall evidence

Device product

Medline Convenience kits used for various procedures: 1) ANGIO CONSOLIDATED PACK, Model Number: DYNJHTCAD1; 2) ANGIOGRAPHY TRAY-LF, Model Number: DYNJ05350V; 3) ANGIOGRAPHY PACK, Model Number: DYNJ38144C

Z-1590-2025

March 03, 2025

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 96510
Status
Ongoing
Classification
Class II
Quantity
2,118 units
Official record key
device-enforcement:Z-1590-2025

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) DYNJHTCAD1, UDI-DI: 10888277087583(each), 40888277087584(case), Lot Number: 24JBS743; 2) DYNJ05350V, UDI-DI: 10193489316629(each), 40193489316620(case), Lot Number: 24JBU500; 3) DYNJ38144C, UDI-DI: 10193489854916(each), 40193489854917(case), Lot Number: 24KBD294

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.