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Recall Observatory FDA recall evidence

Device product

DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Outpatient Major 89-3865.12;

Z-1410-2020

February 04, 2020

Class II

Product summary

Firm
Deroyal Industries, Inc. Lafollette
Event
Event 84889
Status
Terminated
Classification
Class II
Quantity
2,100 units total
Official record key
device-enforcement:Z-1410-2020

Official wording

Reason: Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.

Code information: Catalog number 9541NA, lot numbers 2708DJ1, 3008DJ1, 3008DSJ1 and 4418GSJ; Outpatient Major 89-3865.12, Lot numbers: 47061206 exp. 06/01/2022, 49505579 exp. 03/01/2023, 4955103 exp. 03/01/2023

Distribution pattern: US: Rhode Island and New Jersey Federal government agency: V.A Med Ctr East Orange

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    particulate
  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    bioburden, unknown microbiological flora, and unknown particulate contamination