Skip to content
Recall Observatory FDA recall evidence

Device product

Medline Convenience kits used for various procedures: 1) CSTM PACEMAKER DRAPE PACK, Model Number: DYNJCD0339

Z-1607-2025

March 03, 2025

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 96510
Status
Ongoing
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-1607-2025

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) DYNJCD0339, UDI-DI: 10195327483753(each), 40195327483754(case), Lot Number: 24KBK055

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.