Device product

DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Ocular Plastics Pack 89-6498.13

Z-1419-2020

February 04, 2020

Class II

Product summary

Firm: Deroyal Industries, Inc. Lafollette
Event: Event 84889
Status: Terminated
Classification: Class II
Quantity: 2100 units
Official record key: device-enforcement:Z-1419-2020

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; ASC Ocular Plastics Pack 89-6498.13, Lot numbers: 49227281 exp. 08/01/2023, 49520963 exp. 09/01/2023

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