Home / Recalls / Deroyal Industries, Inc. Lafollette / Z-1419-2020

Z-1419-2020 Class II Terminated

Recalled by Deroyal Industries, Inc. Lafollette — La Follette, TN

Recall Details

Product Type
Devices
Report Date
March 11, 2020
Initiation Date
February 4, 2020
Termination Date
April 1, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2100 units

Product Description

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

Reason for Recall

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

Distribution Pattern

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

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

Other recalls by Deroyal Industries, Inc. Lafollette

  • Z-2499-2021 Class I — DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Se (September 2, 2021)
  • Z-1483-2020 Class II — Teleflex Pilling Aortic Punch, 4.0mm. Sterile, Rx Only, disposable. Included as (February 6, 2020)
  • Z-1414-2020 Class II — DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the follo (February 4, 2020)
  • Z-1415-2020 Class II — DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the follo (February 4, 2020)
  • Z-1416-2020 Class II — DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the follo (February 4, 2020)
  • Z-1412-2020 Class II — DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the follo (February 4, 2020)
  • Z-1413-2020 Class II — DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the follo (February 4, 2020)
  • Z-1418-2020 Class II — DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the follo (February 4, 2020)
  • Z-1417-2020 Class II — DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the follo (February 4, 2020)
  • Z-1410-2020 Class II — DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the follo (February 4, 2020)