FDA Device recall Z-1419-2020
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns
- FDA Device
- Class II
- terminated
- Published 2020-03-11
On 2020-03-11 the FDA classified a Class II recall of DeRoyal Sterile Custom Kits containing Cardinal Health Gowns by Deroyal Industries Lafollette, citing cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1419-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-02-04 |
| Published | 2020-03-11 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Deroyal Industries Lafollette |
| Distribution | NJ, RI |
Product
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Ocular Plastics Pack 89-6498.13
Reason
Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Identifiers
| code_info | Catalog number 9541NA, lot numbers 2708DJ1, 3008DJ1, 3008DSJ1 and 4418GSJ; ASC Ocular Plastics Pack 89-6498.13, Lot…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1419-2020%22
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