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Recall Observatory FDA recall evidence

Device product

Surgical convenience kits labeled as: MEDLINE CABG PACK, Reorder Number DYNDA2827

Z-1112-2023

December 07, 2022

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 91483
Status
Ongoing
Classification
Class II
Quantity
80 units
Official record key
device-enforcement:Z-1112-2023

Official wording

Reason: The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.

Code information: GTIN 401934899531530, Lot # 22HMH432

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.