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Recall Observatory FDA recall evidence

Device product

Medline brand, medical procedure convenience kits, labeled as: a) SET UP PACK, REF DYNJ36320A; b) ANGIOGRAM WRO-LF, REF DYNJ41876B

Z-0154-2025

September 04, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 95415
Status
Ongoing
Classification
Class II
Quantity
312 units
Official record key
device-enforcement:Z-0154-2025

Official wording

Reason: It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Code information: a) DYNJ36320A, UDI/DI 40889942245230 (each), 10889942245239 (case), Lot Numbers: 24ABC836; b) DYNJ41876B, UDI/DI 40193489563086 (each), 10193489563085 (case), Lot Numbers: 23LBM850

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

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    sterile product if the vendor seal of the pouch is opened/unsealed