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Recall Observatory FDA recall evidence

Device product

Medline Convenience kits used for various procedures: 1) PAIN PACK, Model Number: DYNJ67577A; 2) PAIN TRIAL PACK, Model Number: DYNJ67576A;

Z-1588-2025

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-1588-2025

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) DYNJ67577A, UDI-DI: 10193489980349(each), 40193489980340(case), Lot Number: 24JBX252; 2) DYNJ67576A, UDI-DI: 10193489980455(each), 40193489980456(case), Lot Number: 24JBX286

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.